# K231459: HepaFatSmart (V2.0.0)

- Pathway: 510(k) (Special)
- Applicant: Resonance Health Analysis Services Pty, Ltd.
- Decided: Jun 20, 2023 after 32 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: 9 generations back to K962061 (1996). 20 ancestors in all.
No later device cites it as a predicate yet.
4 of 21 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.
- K201039: HepaFat-AI, Resonance Health Analysis Services Pty, Ltd. (2020) Summary page 6.

## Indications for use
HepaFatSmart is intended for the quantitative measurement of volumetric liver fat fraction (VLFF), proton density fat fraction (PDFF) and steatosis grading. HepaFatSmart is an application that is used for the non-invasive evaluation of liver tissue by utilising magnetic resonance images to evaluate 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. Support clinical diagnoses in individuals with confirmed or suspected fatty liver disease; Support the subsequent clinical decision making processes for patients under management for fatty liver related disease or metabolic syndromes; Aid in the assessment and screening of living donors for liver transplant. Results, when interpreted by a trained physician can be used to support clinical diagnoses about the status of liver fat content, the subsequent clinical decision making processes for the management of fatty liver related diseases, metabolic syndromes, liver donor screening and lifestyle change. HepaFatSmart can be used to analyse the MRI images of patients of all populations independent of age and gender, with suspected clinical conditions related to the level of liver fat.

Source page: https://510kreport.com/device/K231459
Methodology: https://510kreport.com/methodology