Tomographic Imager Combining Emission Computed Tomography With Nuclear Magnetic Resonance
Regulation 892.1200
2510(k)s in 12 months (15 all time)
0recalls in 12 months (9 all time)
9recalls that name a 510(k)
Top companies in OUO
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jul 17, 2026 | K253963 | Cubresa BrainPET Cubresa, Inc., CA | OUO |
| Jan 15, 2026 | K253023 | BIOGRAPH One Siemens Healthineers AG, DE | OUO |
| May 24, 2024 | K234154 | uPMR 790 Shanghai United Imaging Healthcare Co., Ltd., CN | OUO |
| Nov 14, 2022 | K222540 | uPMR 790 Shanghai United Imaging Healthcare Co., Ltd., CN | OUO |
| Jan 20, 2022 | K213709 | SIGNA PET/MR Ge Medical Systems, LLC | OUO |
| May 11, 2020 | K200213 | Biograph mMR with syngo MR E11P-AP01 system software Siemens Medical Solutions USA, Inc. | OUO |
| Nov 20, 2019 | K192672 | uPMR 790 Shanghai United Imaging Healthcare Co., Ltd., CN | OUO |
| Feb 27, 2019 | K183014 | uPMR 790 Shanghai United Imaging Healthcare Co., Ltd., CN | OUO |
| Nov 14, 2017 | K172531 | Biograph mMR with mMR Angio Transfer Option Siemens Medical Solutions USA, Inc. | OUO |
| Feb 28, 2017 | K163234 | Biograph mMR with syngo MR E11P system software Siemens Medical Solutions USA, Inc. | OUO |
| Feb 14, 2017 | K163619 | SIGNA PET/MR Ge Medical Systems, LLC | OUO |
| Nov 24, 2014 | K142098 | SIGNA PET/MR Ge Medical Systems, LLC | OUO |
| Nov 12, 2013 | K133226 | BIOGRAPH MMR Siemens Medical Solutions USA, Inc. | OUO |
| Nov 23, 2011 | K103483 | INGENUITY TF PET/MR Philips Healthcare (Cleveland) | OUO |
| Jun 8, 2011 | K103429 | BIOGRAPH MMR Siemens Medical Solutions USA, Inc. | OUO |
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