OUO

Tomographic Imager Combining Emission Computed Tomography With Nuclear Magnetic Resonance

Product code

OUO

Device name

Tomographic Imager Combining Emission Computed Tomography With Nuclear Magnetic Resonance

Device class

Class 2

21 CFR

21 CFR 892.1200

Medical specialty

Radiology

Marketing pathway

510(K)

510(k) clearances (last 3 years)

3

Summaries archived here

3 (direct download)

510(k) clearances (all years, FDA)

15 (all years; only the last 3 years are listed here)

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.

Definition text from the FDA device classification database (U.S. federal government work, public domain).

510(k) clearances, last 3 years (3)

Last three years. Most recent: 2026-07-17.

3 summaries are archived here for direct download.