FDA 510(k) Applications for Medical Device Product Code "OUO"
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K142098 | GE MEDICAL SYSTEMS, LLC | SIGNA PET/MR | 11/24/2014 |
| K213709 | GE Medical Systems, LLC | SIGNA PET/MR | 01/20/2022 |
| K163619 | GE Medical Systems, LLC | SIGNA PET/MR | 02/14/2017 |
| K103483 | PHILIPS HEALTHCARE (CLEVELAND) | INGENUITY TF PET/MR | 11/23/2011 |
| K192672 | Shanghai United Imaging Healthcare Co., Ltd | uPMR 790 | 11/20/2019 |
| K183014 | Shanghai United Imaging Healthcare Co., Ltd. | uPMR 790 | 02/27/2019 |
| K222540 | Shanghai United Imaging Healthcare Co., Ltd. | uPMR 790 | 11/14/2022 |
| K103429 | SIEMENS MEDICAL SOLUTIONS USA INC. | BIOGRAPH MMR | 06/08/2011 |
| K133226 | SIEMENS MEDICAL SOLUTIONS USA, INC. | BIOGRAPH MMR | 11/12/2013 |
| K172531 | Siemens Medical Solutions USA, Inc. | Biograph mMR with mMR Angio Transfer Option | 11/14/2017 |
| K163234 | Siemens Medical Solutions USA, Inc. | Biograph mMR with syngo MR E11P system software | 02/28/2017 |
| K200213 | Siemens Medical Solutions, USA, Inc. | Biograph mMR with syngo MR E11P-AP01 system software | 05/11/2020 |
Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact
