510(k) · Cleared
ClearedHepaFat-AI
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 Dec 7, 2020 as substantially equivalent to K122035 (Resonance Health Analysis Services Pty, Ltd., 2013) after a 231-day review. Its family tree reaches back 8 generations to 1996. 4 of the 22 devices in its family, counting itself, have a Class I recall. 2 later devices descend from it.
- Decided
- Dec 7, 2020
- Review
- 231 days
- Class
- Class II
- Product code
- LNH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 8 generations to K962061 (1996). 19 ancestors in all, the oldest K940172 (1994). 2 later devices descend from it, 2 citing it directly. 4 of the 22 devices in this family, counting this one, have a Class I recall.
- Root · 8 generations backK962061 Magnetic Resonance Diagnostic SystemGE Medical Systems · 1996 · Recalled
- 7 generations backK012200 1.5T Infinity Twinspeed MR SystemGE Medical Systems · 2001 · Recalled (Class I)
- 6 generations backK013636 Signa Infinity MR System with Excite TechnologyGE Medical Systems · 2002 · Recalled (Class I)
- 5 generations backK041476 GE Signa Excite 1.5T MR System, GE Signa Excite 3.0T MR SystemGe Medical Systems, LLC · 2004 · Recalled (Class I)
- 4 generations backK052293 GE 1.5T and 3.0T Signa HDX MR SystemGe Medical Systems, LLC · 2005 · Recalled
- 3 generations backK072998 Ideal Software Option for GE MR ScannersGe Medical Systems, LLC · 2007
- 2 generations backK103411 Ideal IQ Software OptionGE Medical Systems · 2011
- 1 generation backK122035 Hepafat ScanResonance Health Analysis Services Pty, Ltd. · 2013
- This deviceK201039 HepaFat-AIResonance Health Analysis Services Pty, Ltd. · 2020
- Descendant · cites it directly · 0 of its ownK231459 HepaFatSmart (V2.0.0)Resonance Health Analysis Services Pty, Ltd. · 2023
- Descendant · cites it directly · 0 of its ownK213776 LiverSmartResonance Health Analysis Services Pty, Ltd. · 2021
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
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 |
|---|---|---|---|---|---|
| −8 | K962061 | Magnetic Resonance Diagnostic System | GE Medical Systems | 1996 | 2 |
| −7 | K012200 | 1.5T Infinity Twinspeed MR System | GE Medical Systems | 2001 | Class I |
| −6 | K013636 | Signa Infinity MR System with Excite Technology | GE Medical Systems | 2002 | Class I |
| −5 | K041476 | GE Signa Excite 1.5T MR System, GE Signa Excite 3.0T MR System | Ge Medical Systems, LLC | 2004 | Class I |
| −4 | K052293 | GE 1.5T and 3.0T Signa HDX MR System | Ge Medical Systems, LLC | 2005 | 21 |
| −3 | K072998 | Ideal Software Option for GE MR Scanners | Ge Medical Systems, LLC | 2007 | — |
| −2 | K103411 | Ideal IQ Software Option | GE Medical Systems | 2011 | — |
| −1 | K122035 | Hepafat Scan | Resonance Health Analysis Services Pty, Ltd. | 2013 | — |
| 0 (this device) | K201039 | HepaFat-AI | Resonance Health Analysis Services Pty, Ltd. | 2020 | — |
| +1 | K231459 | HepaFatSmart (V2.0.0) | Resonance Health Analysis Services Pty, Ltd. | 2023 | — |
| +1 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 1 | 0 |
| 2023 | 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? (1)
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…donors for liver transplant PREDICATE INFORMATION HepaFat-AI is substantially equivalent to the predicate device HepaFat-Scan (Resonance Health Analysis Services) – K122035. SUBSTANTIAL EQUIVALENCE INFORMATION The table below summarizes the main similarities and differences between HepaFat-AI and… | 2013 |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 24 years and passes through 3 companies; a new generation was cleared every 2.7 years on median.
- 7 of the 19 ancestors have a recall of any class; 4 have a Class I recall.
- Of its descendants, K231459 (Resonance Health Analysis Services Pty, Ltd., 2023) has gone furthest, with 0 descendants of its own.
- 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. 2020, 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?
HepaFat-AI is indicated to:
• 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
• monitor liver fat content in patients undergoing weight loss management and can be used to
• aid in the assessment and screening of living donors for liver transplant.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K201039 · printed Nov 6, 2026
Cite this page
510(k) Report. “K201039: HepaFat-AI.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K201039
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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