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Parker Quality & Compliance

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Device type

Tomographic Imager Combining Emission Computed Tomography With Nuclear Magnetic Resonance

Product code OUO · Class II · 21 CFR 892.1200 · Radiology

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.

FDA classification database

Recent 510(k)s

Oct 28, 2026

K261676

uPMR Zenith

Shanghai United Imaging Healthcare Co., Ltd.

Recent recalls

No recalls in the archive for OUO.