# K242825: Prenuvo Body Composition

- Pathway: 510(k) (Traditional)
- Applicant: Prenuvo
- Decided: Jan 17, 2025 after 121 days
- Product code: LNH (System, Nuclear Magnetic Resonance Imaging)
- Device class: 2
- Regulation: 21 CFR 892.1000
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
Prenuvo Body Composition is a software medical device (SaMD) which is intended for non-invasive fat, muscle and organ quantification. Designed to utilize DICOM-compliant magnetic-resonance image datasets acquired from compatible MR Systems, it displays the internal structure of the body, including the liver. Other physical parameters derived from the images may also be produced. All reported metrics in the Body Composition Report are known in the practice of medicine. Prenuvo Body Composition is indicated for individuals age 18 years and above.

Source page: https://510kreport.com/device/K242825
Methodology: https://510kreport.com/methodology