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FDA-cleared K242825

Prenuvo Body Composition

Prenuvo

Authorized purpose: Prenuvo Body Composition is software that non-invasively quantifies fat, muscle, and organs from compatible MR DICOM datasets and displays internal body information, including liver and body-composition measurements, for adults age 18 and older.

Modality
MRI
Anatomy
Whole-body anatomy, liver, organs, fat, and muscle
Decision
2025-01-17