# K182218: FerriSmart Analysis System

- Pathway: 510(k) (Traditional)
- Applicant: Resonance Health Analysis Services Pty, Ltd.
- Decided: Nov 30, 2018 after 107 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: 1 generation back to DEN130012 (2013). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- DEN130012: Ferriscan R2-Mri Analysis System, Resonance Health Analysis Services Pty, Ltd. (2013) Summary page 5.
- DEN130012: Ferriscan R2-Mri Analysis System, Resonance Health Analysis Services Pty, Ltd. (2013). Our reading of the summary gave K124065, which is not in FDA’s 510(k) list. The device the summary names is FDA’s De Novo DEN130012, Ferriscan R2-Mri Analysis System (Resonance Health Analysis Services Pty, Ltd.), granted Jan 23, 2013; older De Novo requests were first filed under a 510(k) number, so this links to the grant. Summary page 5.

## Most influential descendants
- K213776: LiverSmart (2021), 0 descendants of its own

## Indications for use
FerriSmart is indicated to: • measure liver iron concentration in individuals with confirmed or suspected systemic iron overload; • monitor liver iron burden in transfusion dependent thalassemia patients and patients with sickle cell disease receiving blood transfusions; • aid in the identification and monitoring of non-transfusion-dependent thalassemia patients receiving therapy with deferasirox.

Source page: https://510kreport.com/device/K182218
Methodology: https://510kreport.com/methodology