OUO
15 FDA 510(k) clearances · Product code
104 daysmedian time to decision
218 days90th percentile
15clearances measured
FDA profile
- Official device name
- Tomographic Imager Combining Emission Computed Tomography With Nuclear Magnetic Resonance
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 892.1200
- Medical specialty
- Radiology
- FDA definition
- Imager that generates both both magnetic resonance (mr) and positron emission tomography (pet) images and provides registration and fusion of these images. Pet and mr images can be acquired either simultaneously or sequentially. Anatomical mr images are used for pet attenuation correction.
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| 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 |
| uPMR 790 (K222540) | Shanghai United Imaging Healthcare Co., Ltd. | 2022-11-14 |
| 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 |
| INGENUITY TF PET/MR (K103483) | Philips Healthcare (Cleveland) | 2011-11-23 |
| BIOGRAPH MMR (K103429) | Siemens Medical Solutions USA, Inc. | 2011-06-08 |
Track OUO automatically
Every clearance here is in the API, with alerts when new ones post.