uPMR 790
FDA 510(k) clearance K222540 · decided 2022-11-14
Clearance details
- K-number
- K222540
- Device name
- uPMR 790
- Applicant
- Shanghai United Imaging Healthcare Co., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2022-08-22
- Decision date
- 2022-11-14
- Days to decision
- 84 days
- Clearance type
- Traditional
- Product code
- OUO
- Device class
- 2
- Regulation number
- 892.1200
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Shanghai, CN
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| Cubresa BrainPET (K253963) | Cubresa, Inc. | 2026-07-17 |
| BIOGRAPH One (K253023) | Siemens Healthineers AG | 2026-01-15 |
| uPMR 790 (K234154) | Shanghai United Imaging Healthcare Co., Ltd. | 2024-05-24 |
| SIGNA PET/MR (K213709) | Ge Medical Systems, LLC | 2022-01-20 |
| 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
No recalls on record reference this clearance.