K-number	K242825
Device name	Prenuvo Body Composition
Applicant	Prenuvo
Product code	LNH
Device class	Class II
Decision date	Jan 17, 2025
Decision	Substantially Equivalent
Regulation	892.1000

AI Summary extracted from FDA summary PDF · never regenerated

Intended use

Prenuvo Body Composition is a software medical device that analyzes DICOM-compliant MRI image datasets to provide non-invasive quantification of body fat, muscle, and organs including the liver. It displays internal body structure and derives other physical parameters from MRI images, indicated for individuals 18 years and older.

Technological characteristics

Not stated in this summary.

Test standards cited

Not stated in this summary.

Substantial equivalence argument

Not stated in this summary.

Extracted by AI from the official FDA summary PDF →

Source

View the full FDA submission: accessdata.fda.gov

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Prenuvo Body Composition

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