2 devices · 2 companies · 2024 to 2026
Product code OUO: Tomographic Imager Combining Emission Computed Tomography With Nuclear Magnetic Resonance
2 devices under product code OUO, 2024 to 2026, from 2 companies. Each record carries FDA's decision, the Indications for Use statement verbatim where the public document carries one (2 of 2 here), the regulation, and MAUDE report counts by product code.
Tomographic Imager Combining Emission Computed Tomography With Nuclear Magnetic Resonance. 21 CFR 892.1200, Class II. 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. MAUDE held 13 adverse-event reports against this product code as of 2026-10-29; reports are unverified and the code is shared by every device of this type.
Retrieved from FDA public records.
Every device, newest decision first
| Decision | Device | Company | Panel | FDA |
|---|---|---|---|---|
| BIOGRAPH OneK253023 · 510(k) | Siemens Healthineers AG | Radiology | database entry | |
| uPMR 790K234154 · 510(k) | Shanghai United Imaging Healthcare Co., Ltd. | Radiology | database entry |
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