# K201039: HepaFat-AI

- Pathway: 510(k) (Traditional)
- Applicant: Resonance Health Analysis Services Pty, Ltd.
- Decided: Dec 7, 2020 after 231 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
Longest line of descent: 8 generations back to K962061 (1996). 19 ancestors in all.
2 later devices descend from it; 2 cite it directly.
4 of 22 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K122035: Hepafat Scan, Resonance Health Analysis Services Pty, Ltd. (2013) Summary page 6.

## Most influential descendants
- K231459: HepaFatSmart (V2.0.0) (2023), 0 descendants of its own
- K213776: LiverSmart (2021), 0 descendants of its own

## Indications for use
HepaFat-AI is indicated to: • Assess the volumetric liver fat fraction, proton density fat fraction and steatosis grade in individuals with confirmed or suspected fatty liver disease; When interpreted by a trained physician, the results can be used to • monitor liver fat content in patients undergoing weight loss management and can be used to • aid in the assessment and screening of living donors for liver transplant.

Source page: https://510kreport.com/device/K201039
Methodology: https://510kreport.com/methodology