OUO — Tomographic Imager Combining Emission Computed Tomography With Nuclear Magnetic Resonance Class II
Classification Details
- Product Code
- OUO
- Device Class
- Class II
- Regulation Number
- 892.1200
- Submission Type
- 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 |
|---|---|---|---|
| K253023 | siemens healthineers | BIOGRAPH One | January 15, 2026 |
| K234154 | shanghai united imaging healthcare co | uPMR 790 | May 24, 2024 |
| K222540 | shanghai united imaging healthcare co | uPMR 790 | November 14, 2022 |
| K213709 | ge medical systems | SIGNA PET/MR | January 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 | November 20, 2019 |
| K183014 | shanghai united imaging healthcare co | uPMR 790 | February 27, 2019 |
| K172531 | siemens medical solutions usa | Biograph mMR with mMR Angio Transfer Option | November 14, 2017 |
| K163234 | siemens medical solutions usa | Biograph mMR with syngo MR E11P system software | February 28, 2017 |
| K163619 | ge medical systems | SIGNA PET/MR | February 14, 2017 |
| K142098 | ge medical systems | SIGNA PET/MR | November 24, 2014 |
| K133226 | siemens medical solutions usa | BIOGRAPH MMR | November 12, 2013 |
| K103483 | philips healthcare (cleveland) | INGENUITY TF PET/MR | November 23, 2011 |
| K103429 | siemens medical solutions usa | BIOGRAPH MMR | June 8, 2011 |