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 Siemens Medical Solutions USA, Inc., Shanghai United Imaging Healthcare Co., Ltd. and Ge Medical Systems, LLC.