510(k) · Cleared
ClearedHepaFatSmart (V2.0.0)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Resonance Health Analysis Services Pty, Ltd. · LNH System, Nuclear Magnetic Resonance Imaging
Cleared on Jun 20, 2023 as substantially equivalent to K122035 (Resonance Health Analysis Services Pty, Ltd., 2013) and 1 other predicate after a 32-day review. Its family tree reaches back 9 generations to 1996. 4 of the 21 devices in its family, counting itself, have a Class I recall.
- Decided
- Jun 20, 2023
- Review
- 32 days
- Class
- Class II
- Product code
- LNH
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 9 generations to K962061 (1996). 20 ancestors in all, the oldest K940172 (1994). No later device cites it as a predicate yet. 4 of the 21 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 deviceK231459 HepaFatSmart (V2.0.0)Resonance Health Analysis Services Pty, Ltd. · 2023
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 deviceK231459 HepaFatSmart (V2.0.0)Resonance Health Analysis Services Pty, Ltd. · 2023
Class I recalls in this family
- K041476 GE Signa Excite 1.5T MR System, GE Signa Excite…5 generations back · 2004
- K030874 GE 3.0T Signa Infinity Twinspeed with Excite MR…6 generations back · 2003
- K013636 Signa Infinity MR System with Excite Technology6 generations back · 2002
- K012200 1.5T Infinity Twinspeed MR System7 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) | K231459 | HepaFatSmart (V2.0.0) | Resonance Health Analysis Services Pty, Ltd. | 2023 | — |
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 |
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.
Top candidate predicates for a new LNH device
- #1 K213693 MAGNETOM Vida with syngo MR XA50Ascore 23.0 · 18 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin 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 |
|---|---|---|---|
| * | K122035 | Hepafat ScanSummary page 6…ated to the level of liver fat. PREDICATE INFORMATION HepaFatSmart is substantially equivalent to the predicate device HepaFat-Scan (Resonance Health Analysis Services- K122035) and better than HepaFat-AI (Resonance Health Services – K201039). SUBSTANTIAL EQUIVALENCE INFORMATION The table below summarize… | 2013 |
| * | K201039 | HepaFat-AISummary page 6…rt is substantially equivalent to the predicate device HepaFat-Scan (Resonance Health Analysis Services- K122035) and better than HepaFat-AI (Resonance Health Services – K201039). SUBSTANTIAL EQUIVALENCE INFORMATION The table below summarizes the main similarities and differences between HepaFat-AI and th… | 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 · 5 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 · 6 generations back · ◆ in the 2003 ancestors bar of FIG. 11 Class I recall
- K013636Signa Infinity MR System with Excite TechnologyGE Medical Systems · 2002 · 6 generations back · ◆ on the line of descent in FIG. 11 Class I recall
- K0122001.5T Infinity Twinspeed MR SystemGE Medical Systems · 2001 · 7 generations back · ◆ on the line of descent in FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 27 years and passes through 3 companies; a new generation was cleared every 2.5 years on median.
- 7 of the 20 ancestors have a recall of any class; 4 have a Class I recall.
- 1 other device also cites its predicate K122035.
How does its category compare?
All LNH devicesLNH System, Nuclear Magnetic Resonance Imaging: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, this device’s year, is highlighted.
FDA decisions per year · LNH
26in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LNH
122in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LNH
8in 2025
Class I (8 since 2007) Class II/III not classified
Adverse event reports per year · LNH
1,263in 2025
MAUDE reports naming product code LNH, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 12 | 35 | 25 | 114 |
| 2008 | 19 | 53 | 12 | 167 |
| 2009 | 17 | 70 | 7 | 194 |
| 2010 | 12 | 94 | 17 | 165 |
| 2011 | 16 | 81 | 11 | 182 |
| 2012 | 22 | 89 | 5 | 170 |
| 2013 | 19 | 108 | 2 | 107 |
| 2014 | 17 | 108 | 13 | 119 |
| 2015 | 19 | 140 | 12 (2) | 113 |
| 2016 | 20 | 108 | 1 | 135 |
| 2017 | 18 | 98 | 0 | 121 |
| 2018 | 29 | 128 | 71 | 158 |
| 2019 | 26 | 62 | 5 | 158 |
| 2020 | 32 | 121 | 4 | 98 |
| 2021 | 27 | 87 | 41 | 84 |
| 2022 | 30 | 74 | 13 | 138 |
| 2023 | 30 | 124 | 10 (1) | 159 |
| 2024 | 26 | 104 | 4 | 281 |
| 2025 | 26 | 122 | 8 (5) | 1,263 |
| 2026 | 24 | 126 | 43 | — |
What is it indicated for?
HepaFatSmart is intended for the quantitative measurement of volumetric liver fat fraction (VLFF), proton density fat fraction (PDFF) and steatosis grading. HepaFatSmart is an application that is used for the non-invasive evaluation of liver tissue by utilising magnetic resonance images to evaluate the difference in resonance frequencies between hydrogen nuclei in water and triglyceride fat. The quantitative triglyceride fat fraction is based on the…
Read the full statement (207 words)
HepaFatSmart is intended for the quantitative measurement of volumetric liver fat fraction (VLFF), proton density fat fraction (PDFF) and steatosis grading.
HepaFatSmart is an application that is used for the non-invasive evaluation of liver tissue by utilising magnetic resonance images to evaluate the difference in resonance frequencies between hydrogen nuclei in water and triglyceride fat. The quantitative triglyceride fat fraction is based on the measurement of a magnetic resonance parameter that reflects the ratio of the proton density signal of triglyceride fat to the total proton density signal in the liver.
Support clinical diagnoses in individuals with confirmed or suspected fatty liver disease;
Support the subsequent clinical decision making processes for patients under management for fatty liver related disease or metabolic syndromes;
Aid in the assessment and screening of living donors for liver transplant.
Results, when interpreted by a trained physician can be used to support clinical diagnoses about the status of liver fat content, the subsequent clinical decision making processes for the management of fatty liver related diseases, metabolic syndromes, liver donor screening and lifestyle change.
HepaFatSmart can be used to analyse the MRI images of patients of all populations independent of age and gender, with suspected clinical conditions related to the level of liver fat.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K231459 · printed Nov 6, 2026
Cite this page
510(k) Report. “K231459: HepaFatSmart (V2.0.0).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K231459
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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