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., Ge Medical Systems, LLC and Siemens Healthineers AG.
FDA 510(k) Cleared Tomographic Imager Combining Emission Computed Tomography With Nuclear Magnetic Resonance Devices (Product Code OUO)
About Product Code OUO - Regulatory Context
510(k) Submission Activity
14 total 510(k) submissions under product code OUO since 2011, with 14 receiving FDA clearance (average review time: 116 days).
Submission volume has increased in recent years - 2 submissions in the last 24 months compared to 1 in the prior period - suggesting growing market activity in this device classification.
FDA Review Time
Recent submissions under OUO have taken an average of 133 days to reach a decision - up from 113 days historically. Manufacturers should account for longer review timelines in current project planning.
OUO devices are reviewed by the Radiology panel. Browse all Radiology devices →