Radiology

uPMR 790

Shanghai United Imaging Healthcare Co., Ltd.

FDA-cleared AI medical device

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 Submission Metadata

Submission number
K234154
Decision date
May 2024
FDA panel
Radiology
Product code
OUO
Clinical task (npj)
quantification/feature localization
Data modality (npj)
Images

This entry is sourced from the FDA AI/ML-Enabled Medical Devices list. No editorial review yet — the catalogue may add a deeper review of this device in future.

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