510(k) · Cleared
ClearedHepafat Scan
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 13, 2013 as substantially equivalent to K103411 (GE Medical Systems, 2011) and 1 other predicate after a 520-day review. Its family tree reaches back 7 generations to 1996. 4 of the 22 devices in its family, counting itself, have a Class I recall. 3 later devices descend from it.
- Decided
- Dec 13, 2013
- Review
- 520 days
- Class
- Class II
- Product code
- LNH
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 7 generations to K962061 (1996). 18 ancestors in all, the oldest K940172 (1994). 3 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 · 7 generations backK962061 Magnetic Resonance Diagnostic SystemGE Medical Systems · 1996 · Recalled
- 6 generations backK012200 1.5T Infinity Twinspeed MR SystemGE Medical Systems · 2001 · Recalled (Class I)
- 5 generations backK013636 Signa Infinity MR System with Excite TechnologyGE Medical Systems · 2002 · Recalled (Class I)
- 4 generations backK041476 GE Signa Excite 1.5T MR System, GE Signa Excite 3.0T MR SystemGe Medical Systems, LLC · 2004 · Recalled (Class I)
- 3 generations backK052293 GE 1.5T and 3.0T Signa HDX MR SystemGe Medical Systems, LLC · 2005 · Recalled
- 2 generations backK072998 Ideal Software Option for GE MR ScannersGe Medical Systems, LLC · 2007
- 1 generation backK103411 Ideal IQ Software OptionGE Medical Systems · 2011
- This deviceK122035 Hepafat ScanResonance Health Analysis Services Pty, Ltd. · 2013
- Descendant · cites it directly · 2 of its ownK201039 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 · 2 generations on · 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…4 generations back · 2004
- K030874 GE 3.0T Signa Infinity Twinspeed with Excite MR…5 generations back · 2003
- K013636 Signa Infinity MR System with Excite Technology5 generations back · 2002
- K012200 1.5T Infinity Twinspeed MR System6 generations back · 2001
Most influential descendants
Showing 3 of 3 · See all- K201039HepaFat-AIResonance Health Analysis Services Pty, Ltd. · 2020 · cites it directly2descendants
- K231459HepaFatSmart (V2.0.0)Resonance Health Analysis Services Pty, Ltd. · 2023 · cites it directly0descendants
- K213776LiverSmartResonance Health Analysis Services Pty, Ltd. · 2021 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K962061 | Magnetic Resonance Diagnostic System | GE Medical Systems | 1996 | 2 |
| −6 | K012200 | 1.5T Infinity Twinspeed MR System | GE Medical Systems | 2001 | Class I |
| −5 | K013636 | Signa Infinity MR System with Excite Technology | GE Medical Systems | 2002 | Class I |
| −4 | K041476 | GE Signa Excite 1.5T MR System, GE Signa Excite 3.0T MR System | Ge Medical Systems, LLC | 2004 | Class I |
| −3 | K052293 | GE 1.5T and 3.0T Signa HDX MR System | Ge Medical Systems, LLC | 2005 | 21 |
| −2 | K072998 | Ideal Software Option for GE MR Scanners | Ge Medical Systems, LLC | 2007 | — |
| −1 | K103411 | Ideal IQ Software Option | GE Medical Systems | 2011 | — |
| 0 (this device) | K122035 | Hepafat Scan | Resonance Health Analysis Services Pty, Ltd. | 2013 | — |
| +1 | K201039 | HepaFat-AI | Resonance Health Analysis Services Pty, Ltd. | 2020 | — |
| +1 | K231459 | HepaFatSmart (V2.0.0) | Resonance Health Analysis Services Pty, Ltd. | 2023 | — |
| +2 | 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 |
|---|---|---|
| 2020 | 1 | 0 |
| 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? (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 |
|---|---|---|---|
| * | K103411 | Ideal IQ Software OptionSummary page 1…ance Diagnostic Device (21 CFR 892. 1000) PRODUCT CODE: 90 LNH TRADE NAME: HepaFat-Scan PREDICATE DEVICE(S); K 103411: IDEAL IQ Software Option K043271: R2-MRI Analysis System DEVICE DESCRIPTION: St… | 2011 |
| * | K043271 | R2-Mri Analysis SystemSummary page 1…PRODUCT CODE: 90 LNH TRADE NAME: HepaFat-Scan PREDICATE DEVICE(S); K 103411: IDEAL IQ Software Option K043271: R2-MRI Analysis System DEVICE DESCRIPTION: Standalone software application to facilitate the import and… | 2005 |
What descends from it? (3)
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 · 4 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 · 5 generations back · ◆ in the 2003 ancestors bar of FIG. 11 Class I recall
- K013636Signa Infinity MR System with Excite TechnologyGE Medical Systems · 2002 · 5 generations back · ◆ on the line of descent in FIG. 11 Class I recall
- K0122001.5T Infinity Twinspeed MR SystemGE Medical Systems · 2001 · 6 generations back · ◆ on the line of descent in FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 17 years and passes through 3 companies; a new generation was cleared every 2.4 years on median.
- 7 of the 18 ancestors have a recall of any class; 4 have a Class I recall.
- Of its descendants, K201039 (Resonance Health Analysis Services Pty, Ltd., 2020) has gone furthest, with 2 descendants of its own.
- 1 other device also cites its predicate K103411.
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. 2013, 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-Scan is a software device intended for quantitative measurement of the triglyceride fat fraction in magnetic resonance images of the liver. It utilises magnetic resonance images that exploit 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.
When interpreted by a trained physician, the results provide information that can aid in diagnosis.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K122035 · printed Nov 6, 2026
Cite this page
510(k) Report. “K122035: Hepafat Scan.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K122035
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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