Tomographic Imager Combining Emission Computed Tomography With Nuclear Magnetic Resonance

OUO is the FDA product code for Tomographic Imager Combining Emission Computed Tomography With Nuclear Magnetic Resonance, a class II device type, regulated under 21 CFR 892.1200. FDA's definition for this code reads: "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". As of 2026-09-10, FDA records hold 15 510(k) clearances under this code, the most recent dated 2026-07-17, and 9 recalls.