Tomographic Imager Combining Emission Computed Tomography With Nuclear Magnetic Resonance
The Tomographic Imager Combining Emission Computed Tomography with Nuclear Magnetic Resonance (product code OUO) is a hybrid imaging system that generates both MRI and PET images, providing registration and fusion of these modalities for simultaneous or sequential acquisition. Anatomical MR images are used for PET attenuation correction, resulting in integrated functional and structural imaging. As an FDA Class 2 device under regulation 892.1200, it requires 510(k) premarket clearance and falls within the Radiology specialty. The device is not an implant and is not life-sustaining.
Basic Information
- Product Code
- OUO
- Device Class
- FDA class 2
- Regulation Number
- 892.1200
- Medical Specialty
- Radiology
- Review Panel
- RA
- Submission Type
- 1
Device Characteristics
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.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 13 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K234154 | uPMR 790 | May 24, 2024 | Substantially Equivalent | Shanghai United Imaging Healthcare Co., Ltd. |
| K222540 | uPMR 790 | Nov 14, 2022 | Substantially Equivalent | Shanghai United Imaging Healthcare Co., Ltd. |
| K213709 | SIGNA PET/MR | Jan 20, 2022 | Substantially Equivalent | GE Medical Systems, LLC |
| K200213 | Biograph mMR with syngo MR E11P-AP01 system software | May 11, 2020 | Substantially Equivalent | Siemens Medical Solutions, USA, Inc. |
| K192672 | uPMR 790 | Nov 20, 2019 | Substantially Equivalent | Shanghai United Imaging Healthcare Co., Ltd |
| K183014 | uPMR 790 | Feb 27, 2019 | Substantially Equivalent | Shanghai United Imaging Healthcare Co., Ltd. |
| K172531 | Biograph mMR with mMR Angio Transfer Option | Nov 14, 2017 | Substantially Equivalent | Siemens Medical Solutions USA, Inc. |
| K163234 | Biograph mMR with syngo MR E11P system software | Feb 28, 2017 | Substantially Equivalent | Siemens Medical Solutions USA, Inc. |
| K163619 | SIGNA PET/MR | Feb 14, 2017 | Substantially Equivalent | GE Medical Systems, LLC |
| K142098 | SIGNA PET/MR | Nov 24, 2014 | Substantially Equivalent | GE MEDICAL SYSTEMS, LLC |
| K133226 | BIOGRAPH MMR | Nov 12, 2013 | Substantially Equivalent | SIEMENS MEDICAL SOLUTIONS USA, INC. |
| K103483 | INGENUITY TF PET/MR | Nov 23, 2011 | Substantially Equivalent | PHILIPS HEALTHCARE (CLEVELAND) |
| K103429 | BIOGRAPH MMR | Jun 08, 2011 | Substantially Equivalent | SIEMENS MEDICAL SOLUTIONS USA INC. |
FEI Numbers
This FDA classification entry is associated with 11 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 11 registration numbers. Click on an entry to view related FDA registrations.