MR Elastography
MR Elastography is a hardware and software option for Philips Achieva and Ingenia 1.5 T and 3 T MRI systems. It produces images representing stiffness of abdominal tissue, including the…
MR Elastography is a hardware and software option for Philips Achieva and Ingenia 1.5 T and 3 T MRI systems. It produces images representing stiffness of abdominal tissue, including the liver and muscle.
The system synchronises an MR acquisition sequence with an external source of mechanical vibration applied to the patient. Image processing converts the acquired data into tissue-stiffness maps expressed in kilopascals, wave images and confidence maps.
Image Analysis
The analysis tools allow users to draw regions of interest and display stiffness information. Confidence overlays indicate areas where the calculated stiffness may be less dependable, while stiffness maps can be overlaid on anatomical images.
12manufacturers in China registered for this device type
1catalogue number
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 |
| 510(k) | K140666 |
| Record published | 2016-09-23 |
| Record revised | 2023-09-26 (version 4) |
Specifications
| MRI safety | MR Safe |
|---|---|
| Prescription | Prescription only |
| Label carries | serial number |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 98960302636* | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Ingenia | Philips Medical Systems Nederland B.V. | 72 |
| 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 |
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
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.