OUO · Tomographic Imager Combining Emission Computed Tomography With Nuclear Magnetic Resonance
Radiology · 21 CFR 892.1200 · Class 2
Overview
| Product Code | OUO |
|---|---|
| Device Name | Tomographic Imager Combining Emission Computed Tomography With Nuclear Magnetic Resonance |
| Regulation | 21 CFR 892.1200 |
| Device Class | Class 2 |
| Review Panel | Radiology |
Identification
An emission computed tomography system is a device intended to detect the location and distribution of gamma ray- and positron-emitting radionuclides in the body and produce cross-sectional images through computer reconstruction of the data. This generic type of device may include signal analysis and display equipment, patient and equipment supports, radionuclide anatomical markers, component parts, and accessories.
Classification Rationale
Class II.
Recent Cleared Devices (14 of 14)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K253023 | BIOGRAPH One | Siemens Healthineers AG | Jan 15, 2026 | SESE |
| K234154 | uPMR 790 | Shanghai United Imaging Healthcare Co., Ltd. | May 24, 2024 | SESE |
| K222540 | uPMR 790 | Shanghai United Imaging Healthcare Co., Ltd. | Nov 14, 2022 | SESE |
| K213709 | SIGNA PET/MR | Ge Medical Systems, LLC | Jan 20, 2022 | SESE |
| K200213 | Biograph mMR with syngo MR E11P-AP01 system software | Siemens Medical Solutions USA, Inc. | May 11, 2020 | SESE |
| K192672 | uPMR 790 | Shanghai United Imaging Healthcare Co., Ltd. | Nov 20, 2019 | SESE |
| K183014 | uPMR 790 | Shanghai United Imaging Healthcare Co., Ltd. | Feb 27, 2019 | SESE |
| K172531 | Biograph mMR with mMR Angio Transfer Option | Siemens Medical Solutions USA, Inc. | Nov 14, 2017 | SESE |
| K163234 | Biograph mMR with syngo MR E11P system software | Siemens Medical Solutions USA, Inc. | Feb 28, 2017 | SESE |
| K163619 | SIGNA PET/MR | Ge Medical Systems, LLC | Feb 14, 2017 | SESE |
| K142098 | SIGNA PET/MR | Ge Medical Systems, LLC | Nov 24, 2014 | SESE |
| K133226 | BIOGRAPH MMR | Siemens Medical Solutions USA, Inc. | Nov 12, 2013 | SESE |
| K103483 | INGENUITY TF PET/MR | Philips Healthcare (Cleveland) | Nov 23, 2011 | SESE |
| K103429 | BIOGRAPH MMR | Siemens Medical Solutions USA, Inc. | Jun 8, 2011 | SESE |
Top Applicants
- Siemens Medical Solutions USA, Inc. — 5 clearances
- Shanghai United Imaging Healthcare Co., Ltd. — 4 clearances
- Ge Medical Systems, LLC — 3 clearances
- Siemens Healthineers AG — 1 clearance
- Philips Healthcare (Cleveland) — 1 clearance
