510(k) · Cleared
ClearedLiverSmart
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 Dec 29, 2021 as substantially equivalent to K182218 (Resonance Health Analysis Services Pty, Ltd., 2018) and 1 other predicate after a 27-day review. Its family tree reaches back 9 generations to 1996. 4 of the 23 devices in its family, counting itself, have a Class I recall.
- Decided
- Dec 29, 2021
- Review
- 27 days
- Class
- Class II
- Product code
- PCS
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 9 generations to K962061 (1996). 22 ancestors in all, the oldest K940172 (1994). No later device cites it as a predicate yet. 4 of the 23 devices in this family, counting this one, have a Class I recall.
- Root · 9 generations backK962061 Magnetic Resonance Diagnostic SystemGE Medical Systems · 1996 · Recalled
- 5 generations between
- 3 generations backK103411 Ideal IQ Software OptionGE Medical Systems · 2011
- 2 generations backK122035 Hepafat ScanResonance Health Analysis Services Pty, Ltd. · 2013
- 1 generation backK201039 HepaFat-AIResonance Health Analysis Services Pty, Ltd. · 2020
- This deviceK213776 LiverSmartResonance Health Analysis Services Pty, Ltd. · 2021
Show all 9 generations
- Root · 9 generations backK962061 Magnetic Resonance Diagnostic SystemGE Medical Systems · 1996 · Recalled
- 8 generations backK012200 1.5T Infinity Twinspeed MR SystemGE Medical Systems · 2001 · Recalled (Class I)
- 7 generations backK013636 Signa Infinity MR System with Excite TechnologyGE Medical Systems · 2002 · Recalled (Class I)
- 6 generations backK041476 GE Signa Excite 1.5T MR System, GE Signa Excite 3.0T MR SystemGe Medical Systems, LLC · 2004 · Recalled (Class I)
- 5 generations backK052293 GE 1.5T and 3.0T Signa HDX MR SystemGe Medical Systems, LLC · 2005 · Recalled
- 4 generations backK072998 Ideal Software Option for GE MR ScannersGe Medical Systems, LLC · 2007
- 3 generations backK103411 Ideal IQ Software OptionGE Medical Systems · 2011
- 2 generations backK122035 Hepafat ScanResonance Health Analysis Services Pty, Ltd. · 2013
- 1 generation backK201039 HepaFat-AIResonance Health Analysis Services Pty, Ltd. · 2020
- This deviceK213776 LiverSmartResonance Health Analysis Services Pty, Ltd. · 2021
Class I recalls in this family
- K041476 GE Signa Excite 1.5T MR System, GE Signa Excite…6 generations back · 2004
- K030874 GE 3.0T Signa Infinity Twinspeed with Excite MR…7 generations back · 2003
- K013636 Signa Infinity MR System with Excite Technology7 generations back · 2002
- K012200 1.5T Infinity Twinspeed MR System8 generations back · 2001
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K962061 | Magnetic Resonance Diagnostic System | GE Medical Systems | 1996 | 2 |
| −8 | K012200 | 1.5T Infinity Twinspeed MR System | GE Medical Systems | 2001 | Class I |
| −7 | K013636 | Signa Infinity MR System with Excite Technology | GE Medical Systems | 2002 | Class I |
| −6 | K041476 | GE Signa Excite 1.5T MR System, GE Signa Excite 3.0T MR System | Ge Medical Systems, LLC | 2004 | Class I |
| −5 | K052293 | GE 1.5T and 3.0T Signa HDX MR System | Ge Medical Systems, LLC | 2005 | 21 |
| −4 | K072998 | Ideal Software Option for GE MR Scanners | Ge Medical Systems, LLC | 2007 | — |
| −3 | K103411 | Ideal IQ Software Option | GE Medical Systems | 2011 | — |
| −2 | K122035 | Hepafat Scan | Resonance Health Analysis Services Pty, Ltd. | 2013 | — |
| −1 | K201039 | HepaFat-AI | Resonance Health Analysis Services Pty, Ltd. | 2020 | — |
| 0 (this device) | K213776 | LiverSmart | Resonance Health Analysis Services Pty, Ltd. | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1996 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 2 | 0 |
| 2000 | 1 | 0 |
| 2001 | 2 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 1 |
| 2005 | 1 | 0 |
| 2013 | 1 | 0 |
| 2018 | 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.
4 devices in this family have a Class I recall. A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
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 |
|---|---|---|---|
| * | K182218 | FerriSmart Analysis SystemSummary page 5…Special 510(k): LiverSmart Description of the Device LiverSmart is software that utilizes two existing FDA cleared devices, HepaFat-AI (K201039) and FerriSmart (K182218) and combines their respective results into a singular consolidated multi- parametric ‘LiverSmart’ report. LiverSmart automatical… | 2018 |
| * | K201039 | HepaFat-AISummary page 5…Special 510(k): LiverSmart Description of the Device LiverSmart is software that utilizes two existing FDA cleared devices, HepaFat-AI (K201039) and FerriSmart (K182218) and combines their respective results into a singular consolidated multi- parametric ‘LiverSmart’ repor… | 2020 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (4 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K041476GE Signa Excite 1.5T MR System, GE Signa Excite 3.0T MR SystemGe Medical Systems, LLC · 2004 · 6 generations back · ◆ on the line of descent in FIG. 11 Class I recall
- K030874GE 3.0T Signa Infinity Twinspeed with Excite MR SystemGeneral Electric Co. · 2003 · 7 generations back · ◆ in the 2003 ancestors bar of FIG. 11 Class I recall
- K013636Signa Infinity MR System with Excite TechnologyGE Medical Systems · 2002 · 7 generations back · ◆ on the line of descent in FIG. 11 Class I recall
- K0122001.5T Infinity Twinspeed MR SystemGE Medical Systems · 2001 · 8 generations back · ◆ on the line of descent in FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 25 years and passes through 3 companies; a new generation was cleared every 2.4 years on median.
- 7 of the 22 ancestors have a recall of any class; 4 have a Class I recall.
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. 2021, 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?
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…
Read the full statement (119 words)
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.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K213776 · printed Nov 6, 2026
Cite this page
510(k) Report. “K213776: LiverSmart.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K213776
Report an extraction error
Are you the manufacturer?
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