# K213776: LiverSmart

- Pathway: 510(k) (Special)
- Applicant: Resonance Health Analysis Services Pty, Ltd.
- Decided: Dec 29, 2021 after 27 days
- Product code: PCS (Liver Iron Concentration Imaging Companion Diagnostic For Deferasirox)
- Device class: 2
- Regulation: 21 CFR 892.1001
- 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). 22 ancestors in all.
No later device cites it as a predicate yet.
4 of 23 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K182218: FerriSmart Analysis System, Resonance Health Analysis Services Pty, Ltd. (2018) Summary page 5.
- K201039: HepaFat-AI, Resonance Health Analysis Services Pty, Ltd. (2020) Summary page 5.

## Indications for use
LiverSmart is indicated to: For Liver Iron Concentration 1. measure liver iron concentration in individuals with confirmed or suspected systemic iron overload; 2. monitor liver iron burden in transfusion dependent thalassemia patients and patients with sickle cell disease receiving blood transfusions; 3. aid in the identification and monitoring of non-transfusion-dependent thalassemia patients receiving therapy with Deferasirox. For Liver Fat Assessment 1. 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: 2. monitor liver fat content in patients undergoing weight loss management; 3. aid in the assessment and screening of living donors for liver transplant.

Source page: https://510kreport.com/device/K213776
Methodology: https://510kreport.com/methodology