FDA Product Code OUO: Tomographic Imager Combining Emission Computed Tomography With Nuclear Magnetic Resonance
Combined PET-MRI imaging represents the frontier of multimodal diagnostic imaging. FDA product code OUO covers tomographic imagers that simultaneously combine emission CT (PET or SPECT) with MRI.
These hybrid systems acquire functional and anatomical images simultaneously in a single scanning session, providing co-registered metabolic and soft tissue information with superior tissue contrast compared to PET-CT and without ionizing radiation from CT.
OUO devices are Class II medical devices, regulated under 21 CFR 892.1200 and reviewed by the FDA Radiology panel.
Leading manufacturers include Shanghai United Imaging Healthcare Co., Ltd. and Ge Medical Systems, LLC.
List of Tomographic Imager Combining Emission Computed Tomography With Nuclear Magnetic Resonance devices cleared through 510(k)
How to use this database
This page lists all FDA 510(k) submissions for Tomographic Imager Combining Emission Computed Tomography With Nuclear Magnetic Resonance devices (product code OUO). Click any device to view full submission details, including the decision date, manufacturer information, predicate device, and a link to the official FDA record.
These devices fall under the Radiology FDA review panel. Browse all Radiology devices →