510(k) · Cleared
ClearedFerriSmart Analysis System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Resonance Health Analysis Services Pty, Ltd. · PCS Liver Iron Concentration Imaging Companion Diagnostic For Deferasirox
Cleared on Nov 30, 2018 as substantially equivalent to DEN130012 (Resonance Health Analysis Services Pty, Ltd., 2013) and 1 other predicate after a 107-day review. Its family tree reaches back 1 generation to 2013. 1 later device descends from it.
- Decided
- Nov 30, 2018
- Review
- 107 days
- Class
- Class II
- Product code
- PCS
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to DEN130012 (2013). 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backDEN130012 Ferriscan R2-Mri Analysis SystemResonance Health Analysis Services Pty, Ltd. · 2013
- This deviceK182218 FerriSmart Analysis SystemResonance Health Analysis Services Pty, Ltd. · 2018
- Descendant · cites it directly · 0 of its ownK213776 LiverSmartResonance Health Analysis Services Pty, Ltd. · 2021
Most influential descendants
Showing 1 of 1 · See all- K213776LiverSmartResonance Health Analysis Services Pty, Ltd. · 2021 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | DEN130012 | Ferriscan R2-Mri Analysis System | Resonance Health Analysis Services Pty, Ltd. | 2013 | — |
| 0 (this device) | K182218 | FerriSmart Analysis System | Resonance Health Analysis Services Pty, Ltd. | 2018 | — |
| +1 | K213776 | LiverSmart | Resonance Health Analysis Services Pty, Ltd. | 2021 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in PCS? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new PCS device
- #1 K213776 LiverSmartscore 5.0 · 9 generations · no Class I recall
What was it cleared against? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | DEN130012 | Ferriscan R2-Mri Analysis SystemSummary page 5…PREDICATE INFORMATION FerriSmart is substantially equivalent to the predicate device FerriScan R2-MRI Analysis System (Resonance Health Analysis Services) - DEN130012 / K124065. Resonance Health Analysis Services Pty Ltd Page 2 of 9 ==… | 2013 |
| * | DEN130012 | Ferriscan R2-Mri Analysis System 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. | 2013 |
| † | K043271 | R2-Mri Analysis System | 2005 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K213776 | LiverSmart | 2021 | 0 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has no recall.
- Of its descendants, K213776 (Resonance Health Analysis Services Pty, Ltd., 2021) has gone furthest, with 0 descendants of its own.
How does its category compare?
All PCS devicesPCS Liver Iron Concentration Imaging Companion Diagnostic For Deferasirox: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, this device’s year, is highlighted.
FDA decisions per year · PCS
1in 2021
2026 to Oct 25, outlined.
Median 510(k) review, days · PCS
Too few PCS 510(k)s in any year since 2007 to give a median.
Recalls per year · PCS
No recall names PCS since 2007.
Adverse event reports per year · PCS
No MAUDE report names PCS since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 1 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 1 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 1 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K182218 · printed Nov 5, 2026
Cite this page
510(k) Report. “K182218: FerriSmart Analysis System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K182218
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026