OUO — Tomographic Imager Combining Emission Computed Tomography With Nuclear Magnetic Resonance Class II
FDA product code OUO covers "Tomographic Imager Combining Emission Computed Tomography With Nuclear Magnetic Resonance", a Class II medical device regulated under 21 CFR 892.1200. Submissions are reviewed by the Radiology panel. At least 15 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- OUO
- Device Class
- Class II
- Regulation Number
- 892.1200
- Submission Type
- 510(k)
- Review Panel
- RA
- Medical Specialty
- Radiology
- Implant
- No
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.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K253963 | Cubresa | Cubresa BrainPET | Jul 17, 2026 |
| K253023 | Siemens Healthineers | BIOGRAPH One | Jan 15, 2026 |
| K234154 | Shanghai United Imaging Healthcare Co | uPMR 790 | May 24, 2024 |
| K222540 | Shanghai United Imaging Healthcare Co | uPMR 790 | Nov 14, 2022 |
| K213709 | Ge Medical Systems | SIGNA PET/MR | Jan 20, 2022 |
| K200213 | Siemens Medical Solutions Usa | Biograph mMR with syngo MR E11P-AP01 system software | May 11, 2020 |
| K192672 | Shanghai United Imaging Healthcare Co | uPMR 790 | Nov 20, 2019 |
| K183014 | Shanghai United Imaging Healthcare Co | uPMR 790 | Feb 27, 2019 |
| K172531 | Siemens Medical Solutions Usa | Biograph mMR with mMR Angio Transfer Option | Nov 14, 2017 |
| K163234 | Siemens Medical Solutions Usa | Biograph mMR with syngo MR E11P system software | Feb 28, 2017 |
| K163619 | Ge Medical Systems | SIGNA PET/MR | Feb 14, 2017 |
| K142098 | Ge Medical Systems | SIGNA PET/MR | Nov 24, 2014 |
| K133226 | Siemens Medical Solutions Usa | BIOGRAPH MMR | Nov 12, 2013 |
| K103483 | Philips Healthcare (Cleveland) | INGENUITY TF PET/MR | Nov 23, 2011 |
| K103429 | Siemens Medical Solutions Usa | BIOGRAPH MMR | Jun 8, 2011 |