SIGNA PET/MR
FDA 510(k) clearance K213709 · decided 2022-01-20
Clearance details
- K-number
- K213709
- Device name
- SIGNA PET/MR
- Applicant
- Ge Medical Systems, LLC
- Decision
- Substantially Equivalent
- Date received
- 2021-11-24
- Decision date
- 2022-01-20
- Days to decision
- 57 days
- Clearance type
- Traditional
- Product code
- OUO
- Device class
- 2
- Regulation number
- 892.1200
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Waukesha, WI, US
- Third-party review
- No
- Expedited review
- No
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| Record | Firm | Date |
|---|---|---|
| Cubresa BrainPET (K253963) | Cubresa, Inc. | 2026-07-17 |
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| uPMR 790 (K234154) | Shanghai United Imaging Healthcare Co., Ltd. | 2024-05-24 |
| uPMR 790 (K222540) | Shanghai United Imaging Healthcare Co., Ltd. | 2022-11-14 |
| Biograph mMR with syngo MR E11P-AP01 system software (K200213) | Siemens Medical Solutions USA, Inc. | 2020-05-11 |
| uPMR 790 (K192672) | Shanghai United Imaging Healthcare Co., Ltd. | 2019-11-20 |
| uPMR 790 (K183014) | Shanghai United Imaging Healthcare Co., Ltd. | 2019-02-27 |
| Biograph mMR with mMR Angio Transfer Option (K172531) | Siemens Medical Solutions USA, Inc. | 2017-11-14 |
| Biograph mMR with syngo MR E11P system software (K163234) | Siemens Medical Solutions USA, Inc. | 2017-02-28 |
| SIGNA PET/MR (K163619) | Ge Medical Systems, LLC | 2017-02-14 |
| SIGNA PET/MR (K142098) | Ge Medical Systems, LLC | 2014-11-24 |
| BIOGRAPH MMR (K133226) | Siemens Medical Solutions USA, Inc. | 2013-11-12 |
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| GE SIGNA PET/MR, Tomographic Imager Combining Emission Computed Tomography with Nuclear Ma recall (Z-2309-2025) | GE Medical Systems, LLC | 2025-08-13 |
| Tomographic Imager Combining Emission Computed Tomography With Nuclear Magnetic Resonance: recall (Z-0520-2025) | GE Medical Systems, LLC | 2024-11-22 |
| SIGNA PET/MR, with affected software versions: MP24.0, MP26.0, MP26.1, MR30.0, MR30.1; Tom recall (Z-2466-2024) | GE Medical Systems, LLC | 2024-08-02 |