DeviceClearance

Product code OUO— Radiology

uPMR 790

Classification name
Tomographic Imager Combining Emission Computed Tomography With Nuclear Magnetic Resonance
Device class
Class 2
Regulation
21 CFR 892.1200
Advisory panel
Radiology
Total cleared
15
First cleared
Most recent

FDA classification definition

“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.”

— U.S. Food and Drug Administration, device classification record for product code OUO under 21 CFR 892.1200, via openFDA

Market context for product code OUO

FDA has cleared 15 devices under product code OUO between 2011 and 2026, filed by 6 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

Top applicants under product code OUO

Recent clearances under product code OUO

Data sourced from openFDA. This site is unofficial and independent of the FDA.