# K122035: Hepafat Scan

- Pathway: 510(k) (Traditional)
- Applicant: Resonance Health Analysis Services Pty, Ltd.
- Decided: Dec 13, 2013 after 520 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: 7 generations back to K962061 (1996). 18 ancestors in all.
3 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)
- K103411: Ideal IQ Software Option, GE Medical Systems (2011) Summary page 1.
- K043271: R2-Mri Analysis System, Inner Vision Biometrics Pty, Ltd. (2005) Summary page 1.

## Most influential descendants
- K201039: HepaFat-AI (2020), 2 descendants of its own
- K231459: HepaFatSmart (V2.0.0) (2023), 0 descendants of its own
- K213776: LiverSmart (2021), 0 descendants of its own

## Indications for use
HepaFat-Scan is a software device intended for quantitative measurement of the triglyceride fat fraction in magnetic resonance images of the liver. It utilises magnetic resonance images that exploit the difference in resonance frequencies between hydrogen nuclei in water and triglyceride fat. The quantitative triglyceride fat fraction is based on the measurement of a magnetic resonance parameter that reflects the ratio of the proton density signal of triglyceride fat to the total proton density signal in the liver. When interpreted by a trained physician, the results provide information that can aid in diagnosis.

Source page: https://510kreport.com/device/K122035
Methodology: https://510kreport.com/methodology