De Novo · Granted
GrantedFerriscan R2-Mri 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
Granted on Jan 23, 2013 as a new device type through De Novo after a 21-day review. 2 later devices descend from it.
- Decided
- Jan 23, 2013
- Review
- 21 days
- Class
- Class II
- Product code
- PCS
- Recalls
- None
2 later devices descend from it, 1 citing it directly.
- This deviceDEN130012 Ferriscan R2-Mri Analysis SystemResonance Health Analysis Services Pty, Ltd. · 2013
- Descendant · cites it directly · 1 of its ownK182218 FerriSmart Analysis SystemResonance Health Analysis Services Pty, Ltd. · 2018
- Descendant · 2 generations on · 0 of its ownK213776 LiverSmartResonance Health Analysis Services Pty, Ltd. · 2021
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | DEN130012 | Ferriscan R2-Mri Analysis System | Resonance Health Analysis Services Pty, Ltd. | 2013 | — |
| +1 | K182218 | FerriSmart Analysis System | Resonance Health Analysis Services Pty, Ltd. | 2018 | — |
| +2 | K213776 | LiverSmart | Resonance Health Analysis Services Pty, Ltd. | 2021 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 1 | 0 |
| 2021 | 1 | 0 |
Sources: FDA De Novo database (decision fields), 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
Does it have a predicate?
De Novo decisions do not claim a predicate device.
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K182218 | FerriSmart Analysis System | 2018 | 1 |
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?
- Of its descendants, K182218 (Resonance Health Analysis Services Pty, Ltd., 2018) has gone furthest, with 1 descendant 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. 2013, 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 | — |
https://510kreport.com/device/DEN130012 · printed Nov 6, 2026
Cite this page
510(k) Report. “DEN130012: Ferriscan R2-Mri Analysis System.” Lineage record from FDA De Novo data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/DEN130012
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026