Ingenia
Experience the future of MR today Based on its revolutionary fully sealed BlueSeal magnet, BlueSeal XE lets you experience more productive¹ helium-free MR operations. The BlueSeal XE…
Experience the future of MR today Based on its revolutionary fully sealed BlueSeal magnet, BlueSeal XE lets you experience more productive¹ helium-free MR operations. The BlueSeal XE delivers superb image quality with up to 80% sharper images² even for challenging patients, and performs MRI exams up to 3x faster³ with SmartSpeed Precise accelerations for all anatomies. Fast overall exam-time is achieved by simplifying patient handling at the bore with the guided patient setup. Furthermore, the BlueSeal XE offers an immersive audio-visual experience to help calm patients and guide them through MR exams. ¹ Compared to the Ingenia 1.5T ZBO magnet. ² Compared to Philips SENSE/ C-SENSE imaging. ³ Compared to Philips SENSE imaging.
12manufacturers in China registered for this device type
72catalogue numbers in this listing
27510(k) clearances naming this product code
40recalls on this code
Who Else Makes It
Concentrated in Shanghai (3), Beijing (2), Guangdong (2). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shanghai Chenguang Medical Technologies Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 2 |
| GE Healthcare (China) Co., Ltd. | Beijing | Beijing | Specification developer | 22 |
| Shanghai United Imaging Healthcare Co., Ltd. | Shanghai | Shanghai | Manufacturer | 12 |
| Siemens Shenzhen Magnetic Resonance Ltd. | Shenzhen | Guangdong | Contract manufacturer | 8 |
| GE Healthcare (Tianjin) Company Limited | Tianjin | Tianjin | Specification developer | 5 |
| GE Healthcare (China) Co., Ltd. – Tianjin | Tianjin | Tianjin | Specification developer | 3 |
| Shenzhen RF Tech Co., Ltd. | Shenzhen | Guangdong | Complaint-file establishment | 2 |
| Shanghai Chenshi Medical Instruments Co., Ltd. | Shanghai | Shanghai | Exporter | 2 |
| MRI Division, Beijing Wandong Medical Technology Co., Ltd. | Beijing | Beijing | Manufacturer | 1 |
| Jiangsu Magspin Instrument Co., Ltd. | Kunshan | Jiangsu | Manufacturer | 1 |
| Xingaoyi Medical Equipment Co., Ltd. | Yuyao | Zhejiang | Manufacturer | 1 |
| Sino Canada Health Engineering Research Institute (Hefei) Ltd. (Scheri) | Hefei | Anhui | Complaint-file establishment | 1 |
Record
| Listed by | Philips Medical Systems Nederland B.V., Netherlands |
|---|---|
| FDA product code | LNH |
| Device type | System, Nuclear Magnetic Resonance Imaging |
| Device class | Class 2 |
| Regulation | 21 CFR 892.1000 |
| Establishment | Contract manufacturer, Remanufacturer, Specification developer, Complaint-file establishment, Manufacturer, Exporter |
| Record published | 2024-06-19 |
| Record revised | 2025-12-15 (version 15) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Latex | Contains natural rubber latex |
| Label carries | serial number |
| Storage | Handling environment humidity 20 to 95 % RH; Handling environment atmospheric pressure 70 to 106 KiloPascal; Handling environment temperature -20 to 50 °C |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| Ingenia Elition X | In distribution | |
| Ingenia 3.0T CX | In distribution | |
| BlueSeal SE | In distribution | |
| Evolution Upgrade 1.5T | In distribution | |
| Ingenia 1.5T | In distribution | |
| Ingenia 3.0T | In distribution | |
| Acoustic Hood | In distribution | |
| Ingenia Elition X | In distribution | |
| Ingenia Ambition X | In distribution | |
| Evolution Upgrade 3.0T | In distribution | |
| Ingenia Elition X | In distribution | |
| HA FlexTrak | In distribution | |
| BlueSeal XE | In distribution | |
| Ingenia Elition X | In distribution | |
| Ingenia 3.0T | In distribution | |
| Evolution upgrade 3.0T | In distribution | |
| Ingenia Elition S | In distribution | |
| SmartPath to dStream for 3.0T | In distribution | |
| SmartPath to dStream for XR and 3.0T | In distribution | |
| SmartPath to dStream for 1.5T | In distribution | |
| Upgrade dStream | In distribution | |
| MR 5300 | In distribution | |
| Evolution Upgrade 3.0T | In distribution | |
| Smartpath to dStream for 3.0T | In distribution | |
| SmartPath to Ingenia Elition X | In distribution | |
| BlueSeal SE | In distribution | |
| Upgrade to MR 7700 | In distribution | |
| Ingenia Elition S | In distribution | |
| Evolution Upgrade 1.5T | In distribution | |
| Ingenia 1.5T | In distribution | |
| Ingenia 1.5T | In distribution | |
| Evolution Upgrade 1.5T | In distribution | |
| HA FlexTrak II | In distribution | |
| Ingenia Ambition S | In distribution | |
| Acoustic Hood | In distribution | |
| SmartPath to dStream for 1.5T | In distribution | |
| SmartPath to Ingenia Elition X | In distribution | |
| Ingenia Ambition S | In distribution | |
| Ingenia Elition S | In distribution | |
| SmartPath to Ingenia Elition X | In distribution | |
| Ingenia Ambition X | In distribution | |
| Ingenia Ambition X | In distribution | |
| SmartPath to dStream for XR and 3.0T | In distribution | |
| Ingenia 3.0T CX | In distribution | |
| Ingenia Elition S | In distribution | |
| Ingenia 1.5T | In distribution | |
| MR 7700 | In distribution | |
| Evolution Upgrade 1.5T | In distribution | |
| Evolution Upgrade 3.0T | In distribution | |
| FlexTrak | In distribution | |
| Ingenia Elition X | In distribution | |
| SmartPath to dStream for 3.0T | In distribution | |
| SmartPath to Ingenia Elition X | In distribution | |
| Ingenia Elition X | In distribution | |
| Ingenia 1.5T | In distribution | |
| Evolution Upgrade 3.0T | In distribution | |
| SmartPath to dStream for 1.5T | In distribution | |
| Ingenia Ambition S | In distribution | |
| Trolley | In distribution | |
| SmartPath to Ingenia Elition X | In distribution | |
| Upgrades dStream to R13 | In distribution | |
| Evolution Upgrade 1.5T | In distribution | |
| Ingenia Elition X | In distribution | |
| Ingenia Ambition S | In distribution | |
| BlueSeal XE | In distribution | |
| Ingenia Ambition X | In distribution | |
| BlueSeal QE | In distribution | |
| Tabletop extender | In distribution | |
| Evolution Upgrade 3.0T | In distribution | |
| BlueSeal XE | In distribution | |
| BlueSeal SE | In distribution | |
| Ingenia Elition S | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| System, Nuclear Magnetic Resonance Imaging | GE Medical Systems, L.L.C. | 40 |
| System, Nuclear Magnetic Resonance Imaging | Medtronic Navigation, Inc. | 23 |
| Uni-frame® Thermoplastic | Medtec LLC | 19 |
| Positioning Cushion | Medtec LLC | 18 |
| Posicast® Thermoplastic | Medtec LLC | 18 |
| System, Nuclear Magnetic Resonance Imaging | GE Healthcare (Tianjin) Company Limited | 16 |
| Invivo | Philips DS North America LLC | 15 |
| Type-S™ Thermoplastic | Medtec LLC | 14 |
| Aperto Lucent | Fujifilm Corporation | 13 |
| MRI Integral “T” with Check Valve for Medrad® Spectris MR Injector | Bayer Medical Care Inc. | 11 |
| PPG Finger Band | IVY Biomedical Systems, Inc. | 11 |
| Vac-Lok™ Cushion | Medtec LLC | 10 |
Showing 12 of 478. All products under System, Nuclear Magnetic Resonance Imaging
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K253648 | 2026-02-23 |
| K251808 | 2025-07-11 |
| K251397 | 2025-06-04 |
| K232030 | 2023-08-02 |
| K230972 | 2023-04-28 |
| K223458 | 2023-04-06 |
| K213583 | 2022-05-16 |
| K213516 | 2022-03-03 |
| K212673 | 2021-11-19 |
| K193215 | 2020-04-10 |
| K190461 | 2019-06-04 |
| K183063 | 2019-02-14 |
| K181479 | 2018-08-03 |
| K173079 | 2018-04-04 |
| K173451 | 2018-03-20 |
| K173356 | 2018-03-06 |
| K172920 | 2018-01-22 |
| K162931 | 2017-01-06 |
| K163116 | 2017-01-06 |
| K162940 | 2016-12-30 |
| K143253 | 2015-04-09 |
| K140666 | 2014-06-13 |
| K133526 | 2014-02-12 |
| K131241 | 2013-08-30 |
| K102344 | 2010-11-09 |
| K052078 | 2005-09-07 |
| K052013 | 2005-08-02 |
Recalls Naming This Product
92 recalls name this product by its own identifiers, the UDI on its label.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Philips North America LLC | UDI-DI | 2026-04-14 | Class II | Under Investigation by firm | The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant’s algorithm, leading to the reconstruction voxel size settings in the default MRE scan protocol display | 8 units |
| Philips North America LLC | UDI-DI | 2026-04-14 | Class II | Under Investigation by firm | The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant’s algorithm, leading to the reconstruction voxel size settings in the default MRE scan protocol display | 3 units |
| Philips North America LLC | UDI-DI | 2026-04-14 | Class II | Under Investigation by firm | The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant’s algorithm, leading to the reconstruction voxel size settings in the default MRE scan protocol display | 54 units |
| Philips North America LLC | UDI-DI | 2026-04-14 | Class II | Under Investigation by firm | The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant’s algorithm, leading to the reconstruction voxel size settings in the default MRE scan protocol display | 64 units |
| Philips North America LLC | UDI-DI | 2026-04-14 | Class II | Under Investigation by firm | The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant’s algorithm, leading to the reconstruction voxel size settings in the default MRE scan protocol display | 22 units |
| Philips North America LLC | UDI-DI | 2026-04-14 | Class II | Under Investigation by firm | The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant’s algorithm, leading to the reconstruction voxel size settings in the default MRE scan protocol display | 7 units |
| Philips North America LLC | UDI-DI | 2026-04-14 | Class II | Under Investigation by firm | The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant’s algorithm, leading to the reconstruction voxel size settings in the default MRE scan protocol display | 86 units |
| Philips North America LLC | UDI-DI | 2026-04-14 | Class II | Under Investigation by firm | The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant’s algorithm, leading to the reconstruction voxel size settings in the default MRE scan protocol display | 6 units |
| Philips North America LLC | UDI-DI | 2026-04-14 | Class II | Under Investigation by firm | The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant’s algorithm, leading to the reconstruction voxel size settings in the default MRE scan protocol display | 103 units |
| Philips North America LLC | UDI-DI | 2026-04-14 | Class II | Under Investigation by firm | The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant’s algorithm, leading to the reconstruction voxel size settings in the default MRE scan protocol display | 1 unit |
| Philips North America LLC | UDI-DI | 2026-04-14 | Class II | Under Investigation by firm | The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant’s algorithm, leading to the reconstruction voxel size settings in the default MRE scan protocol display | 14 units |
| Philips North America LLC | UDI-DI | 2026-04-14 | Class II | Under Investigation by firm | The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant’s algorithm, leading to the reconstruction voxel size settings in the default MRE scan protocol display | 3 units |
| Philips North America LLC | UDI-DI | 2026-04-14 | Class II | Under Investigation by firm | The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant’s algorithm, leading to the reconstruction voxel size settings in the default MRE scan protocol display | 15 units |
| Philips North America LLC | UDI-DI | 2025-12-03 | Class II | Software design | The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness maps to viewer Picture Archiving and Communication System (PACS). | 3 units |
| Philips North America LLC | UDI-DI | 2025-12-03 | Class II | Software design | The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness maps to viewer Picture Archiving and Communication System (PACS). | 1 unit |
| Philips North America LLC | UDI-DI | 2025-12-03 | Class II | Software design | The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness maps to viewer Picture Archiving and Communication System (PACS). | 10 units |
| Philips North America LLC | UDI-DI | 2025-12-03 | Class II | Software design | The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness maps to viewer Picture Archiving and Communication System (PACS). | 24 units |
| Philips North America LLC | UDI-DI | 2025-12-03 | Class II | Software design | The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness maps to viewer Picture Archiving and Communication System (PACS). | 6 units |
| Philips North America LLC | UDI-DI | 2025-12-03 | Class II | Software design | The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness maps to viewer Picture Archiving and Communication System (PACS). | 1 unit |
| Philips North America LLC | UDI-DI | 2025-12-03 | Class II | Software design | The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness maps to viewer Picture Archiving and Communication System (PACS). | 21 units |
| Philips North America LLC | UDI-DI | 2025-12-03 | Class II | Software design | The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness maps to viewer Picture Archiving and Communication System (PACS). | 5 units |
| Philips North America LLC | UDI-DI | 2025-12-03 | Class II | Software design | The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness maps to viewer Picture Archiving and Communication System (PACS). | 31 units |
| Philips North America LLC | UDI-DI | 2025-12-03 | Class II | Software design | The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness maps to viewer Picture Archiving and Communication System (PACS). | 6 units |
| Philips North America LLC | UDI-DI | 2025-12-03 | Class II | Software design | The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness maps to viewer Picture Archiving and Communication System (PACS). | 1 unit |
| Philips North America LLC | UDI-DI | 2025-12-03 | Class II | Software design | The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness maps to viewer Picture Archiving and Communication System (PACS). | 3 units |
| Philips North America LLC | UDI-DI | 2025-06-30 | Class II | Device Design | The potential for component failures in the Gradient Coil of the affected MR systems may act as a heat source with a potential to produce smoke and/or fire. | 93 units |
| Philips North America LLC | UDI-DI | 2025-06-30 | Class II | Device Design | The potential for component failures in the Gradient Coil of the affected MR systems may act as a heat source with a potential to produce smoke and/or fire. | 50 units |
| Philips North America LLC | UDI-DI | 2025-06-30 | Class II | Device Design | The potential for component failures in the Gradient Coil of the affected MR systems may act as a heat source with a potential to produce smoke and/or fire. | 2,279 units |
| Philips North America LLC | UDI-DI | 2025-06-30 | Class II | Device Design | The potential for component failures in the Gradient Coil of the affected MR systems may act as a heat source with a potential to produce smoke and/or fire. | 1,467 units |
| Philips North America LLC | UDI-DI | 2025-06-30 | Class II | Device Design | The potential for component failures in the Gradient Coil of the affected MR systems may act as a heat source with a potential to produce smoke and/or fire. | 350 units |
| Philips North America LLC | UDI-DI | 2025-06-30 | Class II | Device Design | The potential for component failures in the Gradient Coil of the affected MR systems may act as a heat source with a potential to produce smoke and/or fire. | 611 units |
| Philips North America LLC | UDI-DI | 2025-06-30 | Class II | Device Design | The potential for component failures in the Gradient Coil of the affected MR systems may act as a heat source with a potential to produce smoke and/or fire. | 690 units |
| Philips North America LLC | UDI-DI | 2025-06-30 | Class II | Device Design | The potential for component failures in the Gradient Coil of the affected MR systems may act as a heat source with a potential to produce smoke and/or fire. | 242 units |
| Philips North America LLC | UDI-DI | 2025-06-30 | Class II | Device Design | The potential for component failures in the Gradient Coil of the affected MR systems may act as a heat source with a potential to produce smoke and/or fire. | 632 units |
| Philips North America LLC | UDI-DI | 2025-06-30 | Class II | Device Design | The potential for component failures in the Gradient Coil of the affected MR systems may act as a heat source with a potential to produce smoke and/or fire. | 15 units |
| Philips North America LLC | UDI-DI | 2025-06-30 | Class II | Device Design | The potential for component failures in the Gradient Coil of the affected MR systems may act as a heat source with a potential to produce smoke and/or fire. | 294 units |
| Philips North America LLC | UDI-DI | 2025-06-30 | Class II | Device Design | The potential for component failures in the Gradient Coil of the affected MR systems may act as a heat source with a potential to produce smoke and/or fire. | 33 units |
| Philips North America LLC | UDI-DI | 2025-06-30 | Class II | Device Design | The potential for component failures in the Gradient Coil of the affected MR systems may act as a heat source with a potential to produce smoke and/or fire. | 26 units |
| Philips North America LLC | UDI-DI | 2025-05-13 | Class II | Software design | Potential for alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application. | 80 units (1 US, 79 OUS) |
| Philips North America LLC | UDI-DI | 2025-05-13 | Class II | Software design | Potential for alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application. | 12 units (OUS only) |
Showing 40 of 92.
Recalls
40 of these are Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2025-03-24 | Class II | Process control | The Quadrature Body Coil (QBC) seal adhesive may fail, creating sharp edges that may come in contact with patients. If the QBC seal becomes loose during the scanning process, the risk to the patient may include skin abrasions, bruises, lace | 14 units (All OUS) | |
| 2025-03-24 | Class II | Process control | The Quadrature Body Coil (QBC) seal adhesive may fail, creating sharp edges that may come in contact with patients. If the QBC seal becomes loose during the scanning process, the risk to the patient may include skin abrasions, bruises, lace | 26 units (7 US, 19 OUS) | |
| 2025-03-24 | Class II | Process control | The Quadrature Body Coil (QBC) seal adhesive may fail, creating sharp edges that may come in contact with patients. If the QBC seal becomes loose during the scanning process, the risk to the patient may include skin abrasions, bruises, lace | 6 units (4 US, 2 OUS) | |
| 2025-03-24 | Class II | Process control | The Quadrature Body Coil (QBC) seal adhesive may fail, creating sharp edges that may come in contact with patients. If the QBC seal becomes loose during the scanning process, the risk to the patient may include skin abrasions, bruises, lace | 3 units OUS | |
| 2025-03-24 | Class II | Process control | The Quadrature Body Coil (QBC) seal adhesive may fail, creating sharp edges that may come in contact with patients. If the QBC seal becomes loose during the scanning process, the risk to the patient may include skin abrasions, bruises, lace | 103 units (37 US, 66 OUS) | |
| 2025-03-24 | Class II | Process control | The Quadrature Body Coil (QBC) seal adhesive may fail, creating sharp edges that may come in contact with patients. If the QBC seal becomes loose during the scanning process, the risk to the patient may include skin abrasions, bruises, lace | 34 units (32 US, 2 OUS) | |
| 2025-03-24 | Class II | Process control | The Quadrature Body Coil (QBC) seal adhesive may fail, creating sharp edges that may come in contact with patients. If the QBC seal becomes loose during the scanning process, the risk to the patient may include skin abrasions, bruises, lace | 12 units (2 US, 10 OUS) | |
| 2025-03-24 | Class II | Process control | The Quadrature Body Coil (QBC) seal adhesive may fail, creating sharp edges that may come in contact with patients. If the QBC seal becomes loose during the scanning process, the risk to the patient may include skin abrasions, bruises, lace | 376 units (37 US, 339 OUS) | |
| 2025-03-24 | Class II | Process control | The Quadrature Body Coil (QBC) seal adhesive may fail, creating sharp edges that may come in contact with patients. If the QBC seal becomes loose during the scanning process, the risk to the patient may include skin abrasions, bruises, lace | 37 units (3 US, 34 OUS) | |
| 2025-03-24 | Class II | Process control | The Quadrature Body Coil (QBC) seal adhesive may fail, creating sharp edges that may come in contact with patients. If the QBC seal becomes loose during the scanning process, the risk to the patient may include skin abrasions, bruises, lace | 26 units (All OUS) | |
| 2025-03-24 | Class II | Process control | The Quadrature Body Coil (QBC) seal adhesive may fail, creating sharp edges that may come in contact with patients. If the QBC seal becomes loose during the scanning process, the risk to the patient may include skin abrasions, bruises, lace | 12 units (5 US, 7 OUS) | |
| 2025-03-24 | Class II | Process control | The Quadrature Body Coil (QBC) seal adhesive may fail, creating sharp edges that may come in contact with patients. If the QBC seal becomes loose during the scanning process, the risk to the patient may include skin abrasions, bruises, lace | 23 units (10 US, 13 OUS) | |
| 2025-03-24 | Class II | Process control | The Quadrature Body Coil (QBC) seal adhesive may fail, creating sharp edges that may come in contact with patients. If the QBC seal becomes loose during the scanning process, the risk to the patient may include skin abrasions, bruises, lace | 121 units (51 US, 70 OUS) | |
| 2025-03-24 | Class II | Process control | The Quadrature Body Coil (QBC) seal adhesive may fail, creating sharp edges that may come in contact with patients. If the QBC seal becomes loose during the scanning process, the risk to the patient may include skin abrasions, bruises, lace | 4 units OUS | |
| 2019-03-25 | Class II | Device Design | Magnet Energization Device (MED) can have a residual voltage on output terminal, may cause electrical shocks to personnel servicing the MED, MDD or connected cabling. | 4 units | 2020-06-04 |
| 2018-12-21 | Class II | Unknown/Undetermined by firm | There is a potential for the ceiling speaker(s) to fall from their position and be pulled to the MR system by the magnetic field. | 11226 total | 2020-11-19 |
| 2018-12-21 | Class II | Unknown/Undetermined by firm | There is a potential for the ceiling speaker(s) to fall from their position and be pulled to the MR system by the magnetic field. | 11226 total | 2020-11-19 |
| 2018-12-21 | Class II | Unknown/Undetermined by firm | There is a potential for the ceiling speaker(s) to fall from their position and be pulled to the MR system by the magnetic field. | 11226 total | 2020-11-19 |
| 2018-12-21 | Class II | Unknown/Undetermined by firm | There is a potential for the ceiling speaker(s) to fall from their position and be pulled to the MR system by the magnetic field. | 11226 total | 2020-11-19 |
| 2018-12-21 | Class II | Unknown/Undetermined by firm | There is a potential for the ceiling speaker(s) to fall from their position and be pulled to the MR system by the magnetic field. | 11226 total | 2020-11-19 |
| 2018-12-21 | Class II | Unknown/Undetermined by firm | There is a potential for the ceiling speaker(s) to fall from their position and be pulled to the MR system by the magnetic field. | 11226 total | 2020-11-19 |
| 2018-12-21 | Class II | Unknown/Undetermined by firm | There is a potential for the ceiling speaker(s) to fall from their position and be pulled to the MR system by the magnetic field. | 11226 total | 2020-11-19 |
| 2018-12-21 | Class II | Unknown/Undetermined by firm | There is a potential for the ceiling speaker(s) to fall from their position and be pulled to the MR system by the magnetic field. | 11226 total | 2020-11-19 |
| 2018-12-21 | Class II | Unknown/Undetermined by firm | There is a potential for the ceiling speaker(s) to fall from their position and be pulled to the MR system by the magnetic field. | 11226 total | 2020-11-19 |
| 2018-12-21 | Class II | Unknown/Undetermined by firm | There is a potential for the ceiling speaker(s) to fall from their position and be pulled to the MR system by the magnetic field. | 11226 total | 2020-11-19 |
| 2018-12-21 | Class II | Unknown/Undetermined by firm | There is a potential for the ceiling speaker(s) to fall from their position and be pulled to the MR system by the magnetic field. | 11226 total | 2020-11-19 |
| 2018-12-21 | Class II | Unknown/Undetermined by firm | There is a potential for the ceiling speaker(s) to fall from their position and be pulled to the MR system by the magnetic field. | 11226 total | 2020-11-19 |
| 2018-12-21 | Class II | Unknown/Undetermined by firm | There is a potential for the ceiling speaker(s) to fall from their position and be pulled to the MR system by the magnetic field. | 11226 total | 2020-11-19 |
| 2018-12-21 | Class II | Unknown/Undetermined by firm | There is a potential for the ceiling speaker(s) to fall from their position and be pulled to the MR system by the magnetic field. | 11226 total | 2020-11-19 |
| 2018-12-21 | Class II | Unknown/Undetermined by firm | There is a potential for the ceiling speaker(s) to fall from their position and be pulled to the MR system by the magnetic field. | 11226 total | 2020-11-19 |
| 2018-12-21 | Class II | Unknown/Undetermined by firm | There is a potential for the ceiling speaker(s) to fall from their position and be pulled to the MR system by the magnetic field. | 11226 total | 2020-11-19 |
| 2018-12-21 | Class II | Unknown/Undetermined by firm | There is a potential for the ceiling speaker(s) to fall from their position and be pulled to the MR system by the magnetic field. | 11226 total | 2020-11-19 |
| 2018-12-21 | Class II | Unknown/Undetermined by firm | There is a potential for the ceiling speaker(s) to fall from their position and be pulled to the MR system by the magnetic field. | 11226 total | 2020-11-19 |
| 2018-12-21 | Class II | Unknown/Undetermined by firm | There is a potential for the ceiling speaker(s) to fall from their position and be pulled to the MR system by the magnetic field. | 11226 total | 2020-11-19 |
| 2018-12-21 | Class II | Unknown/Undetermined by firm | There is a potential for the ceiling speaker(s) to fall from their position and be pulled to the MR system by the magnetic field. | 11226 total | 2020-11-19 |
| 2018-12-21 | Class II | Unknown/Undetermined by firm | There is a potential for the ceiling speaker(s) to fall from their position and be pulled to the MR system by the magnetic field. | 11226 total | 2020-11-19 |
| 2018-12-21 | Class II | Unknown/Undetermined by firm | There is a potential for the ceiling speaker(s) to fall from their position and be pulled to the MR system by the magnetic field. | 11226 total | 2020-11-19 |
| 2018-12-21 | Class II | Unknown/Undetermined by firm | There is a potential for the ceiling speaker(s) to fall from their position and be pulled to the MR system by the magnetic field. | 11226 total | 2020-11-19 |
| 2018-12-21 | Class II | Unknown/Undetermined by firm | There is a potential for the ceiling speaker(s) to fall from their position and be pulled to the MR system by the magnetic field. | 11226 total | 2020-11-19 |
| 2018-12-21 | Class II | Unknown/Undetermined by firm | There is a potential for the ceiling speaker(s) to fall from their position and be pulled to the MR system by the magnetic field. | 11226 total | 2020-11-19 |
PMA Approvals
A premarket approval is the full Class III route, granted on clinical evidence rather than on equivalence to an existing device. It is the highest regulatory bar a device of this type can clear.
| PMA number | Decision | Trade name | Approved to |
|---|---|---|---|
| P860010 | 1988-06-12 | INSTRUMENTARIUM ULF MR IMAGING SYSTEM | Palomex Instrumentarium Corp. |
| P860062 | 1988-05-25 | RESONEX RX4000{TM} MAGNETIC RESONANCE IMAGING SYST | Resonex, Inc. |
| P850043 | 1987-12-30 | MAGNISCAN 5000 MRI SYSTEM | Thomson-Cgr Medical Corp. |
| P830074 | 1987-11-25 | GE SIGNA MAGNETIC RESONANCE DIAGNOSTIC IMAGING SYS | General Electric Co. |
| P840063 | 1987-08-11 | GYROSCAN(TM) | Philips Medical Systems Technologies Ltd |
| P840007 | 1987-04-02 | GYREX, MODELS S3500 & S5000 | Elscint, Inc. |
| P830076 | 1986-10-08 | FONAR NMR WHOLE BODY SCANNER BETA 3000 | Fonar Corp. |
| P830052 | 1986-05-28 | NUCLEAR MAGNETIC RESONANCE SCANNER MODELS NMR 1000 | Philips Medical Systems (Cleveland), Inc. |
| P830051 | 1986-04-30 | TESLACON(TM) NMR IMAGING SYSTEM | Technicare Corp. |
| P830053 | 1985-12-18 | DIASONICS NMR IMAGING SYSTEM | Diasonics, Inc. |
| P830081 | 1985-06-06 | MAGNETOM | Siemens Healthcare Limited |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.