Ingenia
Enables trained physicians to obtain cross-sectional and spectroscopic images of internal structures of the head, body or extremities, in any orientation, representing the spatial…
Enables trained physicians to obtain cross-sectional and spectroscopic images of internal structures of the head, body or extremities, in any orientation, representing the spatial distribution of protons or other nuclei with spin.
4manufacturers in China registered for this device type
3catalogue numbers in this listing
Who Else Makes It
Concentrated in Tianjin (2), Beijing (1), Guangdong (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| GE Healthcare (China) Co., Ltd. | Beijing | Beijing | Specification developer | 22 |
| 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 |
Record
| Listed by | Philips Medical Systems Nederland B.V., Netherlands |
|---|---|
| FDA product code | LNI |
| Device type | System, Nuclear Magnetic Resonance Spectroscopic |
| Device class | Class 2 |
| Regulation | 21 CFR 892.1000 |
| Establishment | Contract manufacturer, Remanufacturer, Specification developer, Complaint-file establishment, Manufacturer, Exporter |
| Record published | 2019-09-23 |
| Record revised | 2025-12-15 (version 9) |
Specifications
| MRI safety | MR Safe |
|---|---|
| Prescription | Prescription only |
| Label carries | serial number |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| Smartpath to dStream for 1.5T | In distribution | |
| Ingenia 3.0T | In distribution | |
| Ingenia 1.5T | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| System, Nuclear Magnetic Resonance Spectroscopic | GE Healthcare (Tianjin) Company Limited | 6 |
| System, Nuclear Magnetic Resonance Spectroscopic | Usa Instruments, Inc. | 2 |
| Magnetom Cima.X | Siemens Healthcare Limited | 2 |
| Magnetom Altea | Siemens Healthineers AG | 2 |
| 1.5T 32-ch Head Coil MR Coil | Siemens Healthcare Limited | 1 |
| CP Flex Coil Large 63 047 | Siemens Healthcare Limited | 1 |
| Magnetom Sola | Siemens Healthineers AG | 1 |
| Hitachi | Hitachi, Ltd. | 1 |
| Breast Array CPL. 047 | Siemens Healthcare Limited | 1 |
| Achieva | Philips Medical Systems Nederland B.V. | 1 |
| 1.5T Loop 7 cm MR coil kit | Siemens Healthcare Limited | 1 |
| PA 36 MR coil set 3T 098 | Siemens Healthcare Limited | 1 |
Showing 12 of 85. All products under System, Nuclear Magnetic Resonance Spectroscopic
Recalls Naming This Product
15 recalls name this product by its own identifiers, the UDI on its label.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| 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 | 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). | 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 | 2025-06-30 | 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 | 2025-05-13 | 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. | 264 units (46 US, 218 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. | 193 units (36 US, 157 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. | 152 units (25 US, 127 OUS) | |
| Philips North America LLC | UDI-DI | 2024-01-03 | 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 US; 735 OUS | |
| Philips North America LLC | UDI-DI | 2023-12-29 | Class III | Under Investigation by firm | An incorrect electrical shock warning label may have been placed on the Liquid Cooling Cabinet (LCC) of affected MR systems. The caution symbol on the incorrect label has a white background instead of yellow, and the label is missing the hi | 7 US; 16 ROW total | |
| Philips North America LLC | UDI-DI | 2023-10-23 | Class II | Under Investigation by firm | Potential component failure in the Gradient Coil could product smoke and/or fire. | 119 units | |
| Philips North America LLC | UDI-DI | 2021-07-30 | Class II | Nonconforming Material/Component | Pressure relief valve 42 psi installed in the magnet assembly instead of a 3.75 psi valve, may result in release of helium gas and cause injury | 3 units US; 24 units OUS | 2023-07-25 |
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.