Tomographic Imager Combining Emission Computed Tomography With Nuclear Magnetic Resonance
GE SIGNA PET/MR is an integrated imaging system that combines magnetic resonance imaging with positron emission tomography. The MR scanner and PET detector acquire complementary image…
GE SIGNA PET/MR is an integrated imaging system that combines magnetic resonance imaging with positron emission tomography. The MR scanner and PET detector acquire complementary image information in the same system, supporting anatomical and functional views within a combined examination.
The listed assembly is one configuration in the SIGNA PET/MR family. GE describes simultaneous PET and MR acquisition as a central part of the platform; individual assemblies and field configurations differ across that family.
Listed Item
SIGNA PETMR System Medical Device Assembly – MDR
Imaging Components
The integrated PET detector operates within the MR scanner environment, so PET and MR data are acquired as parts of one imaging workflow. Reconstruction software combines the acquired data into PET/MR image sets.
The entry identifies a system assembly rather than a standalone detector or software package. Model-specific scanner and reconstruction options depend on the assembled configuration.
Who Else Makes It
Concentrated in Shanghai (1), Guangdong (1), Tianjin (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| 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 |
Record
| Listed by | GE Medical Systems, L.L.C. |
|---|---|
| FDA product code | OUO |
| Device type | Tomographic Imager Combining Emission Computed Tomography With Nuclear Magnetic Resonance |
| Device class | Class 2 |
| Regulation | 21 CFR 892.1200 |
| 510(k) | K142098 |
| Record published | 2016-05-16 |
| Record revised | 2026-01-30 (version 7) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | lot or batch number, manufacturing date, serial number |
| Distribution end date | 2024-05-26 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 5265300-50 | In distribution | |
| 3.0T UAA | In distribution | |
| SIGNA PET MR | In distribution | |
| 3.0T PETMR CMA | In distribution | |
| SIGNA PET MR | In distribution | |
| 5494440 | In distribution | |
| 3.0T LAA | In distribution | |
| 5775930 | Withdrawn | |
| MP24 | Withdrawn | |
| MP24 R03 | Withdrawn | |
| SIGNA PET MR SPiCE Workstation | Withdrawn | |
| SIGNA PET MR | Withdrawn | |
| 5789577 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Symphony™ | Qfix | 3 |
| Flex small 4 MR coil set 3T | Siemens Healthcare Limited | 2 |
| Lithotomy AirShuttle™ | Qfix | 1 |
| ZiFix™ | Qfix | 1 |
| mMR Head | Siemens Healthcare Limited | 1 |
| 3T Loop 4 cm MR coil kit | Siemens Healthcare Limited | 1 |
| mMR Head set | Siemens Healthcare Limited | 1 |
| mMR Head/Neck coil set | Siemens Healthcare Limited | 1 |
| mMR Head/Neck Matrix coil | Siemens Healthcare Limited | 1 |
| mMR Body coil set | Siemens Healthcare Limited | 1 |
| uPMR | Shanghai United Imaging Healthcare Co., Ltd. | 1 |
| 3T Body Matrix MR coil set, Verio | Siemens Healthcare Limited | 1 |
Showing 12 of 22. All products under Tomographic Imager Combining Emission Computed Tomography With Nuclear Magnetic Resonance
Recalls Naming This Product
7 recalls name this product by its own identifiers, the UDI on its label or the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| GE Medical Systems, LLC | UDI-DI | 2025-06-20 | Class II | Equipment maintenance | GE HealthCare has become aware that for certain MR systems (SIGNA Artist, SIGNA Voyager, Discovery MR450 1.5T, Optima MR450w 1.5T, SIGNA Architect, SIGNA Premier, SIGNA UHP, Discovery MR750 3.0T, Discovery MR750w 3.0T, SIGNA Hero, SIGNA PET | 97 units | |
| GE Medical Systems, LLC | UDI-DI | 2025-05-23 | Class II | Device Design | GE HealthCare has become aware that gradient coils for certain MR systems (see affected product list in this letter), under specific conditions, can produce elevated acoustic noise during scanning. As a result, acoustic levels can exceed 99 | ||
| GE Medical Systems, LLC | 510(k) number | 2024-06-14 | Class II | Device Design | GE HealthCare has become aware that for certain MR systems, the system predicted B1+RMS value can exceed the B1+RMS user prescribed limit when scanning in Low SAR Mode and the following two conditions are met: 1. 2D FSE T2 FLAIR OR T2 FLAIR | 123 units | |
| GE Medical Systems, LLC | 510(k) number | 2021-12-23 | Class II | Process control | The magnetic resonance systems could potentially have a cryogen ventilation system that does not meet the venting requirements. | 17,228 devices total in this field correction | |
| GE Medical Systems, LLC | 510(k) number | 2021-06-04 | Class II | Software design | GE Healthcare has recently become aware of an issue on the affected products listed below where the “Patient Orientation” button may inadvertently be clicked when intending to click on the “Save RX” button. This changes the prescribed pati | 71 devices | |
| GE Medical Systems, LLC | 510(k) number | 2020-09-08 | Class II | Process change control | Potential electrical arc flash within the Power Gradient & RF (PGR) Cabinet. | 2021-04-28 | |
| GE Medical Systems, LLC | 510(k) number | 2015-08-31 | Class II | Software design | When performing head or neck scans, the currently displayed SAR values could be lower than the actual SAR in the head as predicted by SAR modeling. The predicted HEAD SAR value from the modeling suggests the actual SAR in the head could exc | 17 | 2018-09-07 |
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.