FDA Product Code
FDA Product Code OUO — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Radiology
- 21 CFR Citation
- 892.1200
510(k) Clearances — 15 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K253963 | Cubresa BrainPET | Cubresa, Inc. | 2026-07-17 | Traditional | PDF ↗ |
| K253023 | BIOGRAPH One | Siemens Healthineers AG | 2026-01-15 | Traditional | PDF ↗ |
| K234154 | uPMR 790 | Shanghai United Imaging Healthcare Co., Ltd. | 2024-05-24 | Traditional | PDF ↗ |
| K222540 | uPMR 790 | Shanghai United Imaging Healthcare Co., Ltd. | 2022-11-14 | Traditional | PDF ↗ |
| K213709 | SIGNA PET/MR | Ge Medical Systems, LLC | 2022-01-20 | Traditional | PDF ↗ |
| K200213 | Biograph mMR with syngo MR E11P-AP01 system software | Siemens Medical Solutions USA, Inc. | 2020-05-11 | Traditional | PDF ↗ |
| K192672 | uPMR 790 | Shanghai United Imaging Healthcare Co., Ltd. | 2019-11-20 | Traditional | PDF ↗ |
| K183014 | uPMR 790 | Shanghai United Imaging Healthcare Co., Ltd. | 2019-02-27 | Traditional | PDF ↗ |
| K172531 | Biograph mMR with mMR Angio Transfer Option | Siemens Medical Solutions USA, Inc. | 2017-11-14 | Traditional | PDF ↗ |
| K163234 | Biograph mMR with syngo MR E11P system software | Siemens Medical Solutions USA, Inc. | 2017-02-28 | Traditional | PDF ↗ |
| K163619 | SIGNA PET/MR | Ge Medical Systems, LLC | 2017-02-14 | Traditional | PDF ↗ |
| K142098 | SIGNA PET/MR | Ge Medical Systems, LLC | 2014-11-24 | Traditional | PDF ↗ |
| K133226 | BIOGRAPH MMR | Siemens Medical Solutions USA, Inc. | 2013-11-12 | Special | PDF ↗ |
| K103483 | INGENUITY TF PET/MR | Philips Healthcare (Cleveland) | 2011-11-23 | Traditional | PDF ↗ |
| K103429 | BIOGRAPH MMR | Siemens Medical Solutions USA, Inc. | 2011-06-08 | Traditional | PDF ↗ |
Product code OUO · Class II · Radiology. Data: openFDA.