510(k) · Cleared
ClearedIdeal IQ Software Option
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
GE Medical Systems · LNH System, Nuclear Magnetic Resonance Imaging
Cleared on Mar 22, 2011 as substantially equivalent to K072998 (Ge Medical Systems, LLC, 2007) after a 120-day review. Its family tree reaches back 6 generations to 1996. 4 of the 18 devices in its family, counting itself, have a Class I recall. 5 later devices descend from it.
- Decided
- Mar 22, 2011
- Review
- 120 days
- Class
- Class II
- Product code
- LNH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K962061 (1996). 12 ancestors in all. 5 later devices descend from it, 2 citing it directly. 4 of the 18 devices in this family, counting this one, have a Class I recall.
- Root · 6 generations backK962061 Magnetic Resonance Diagnostic SystemGE Medical Systems · 1996 · Recalled
- 5 generations backK012200 1.5T Infinity Twinspeed MR SystemGE Medical Systems · 2001 · Recalled (Class I)
- 4 generations backK013636 Signa Infinity MR System with Excite TechnologyGE Medical Systems · 2002 · Recalled (Class I)
- 3 generations backK041476 GE Signa Excite 1.5T MR System, GE Signa Excite 3.0T MR SystemGe Medical Systems, LLC · 2004 · Recalled (Class I)
- 2 generations backK052293 GE 1.5T and 3.0T Signa HDX MR SystemGe Medical Systems, LLC · 2005 · Recalled
- 1 generation backK072998 Ideal Software Option for GE MR ScannersGe Medical Systems, LLC · 2007
- This deviceK103411 Ideal IQ Software OptionGE Medical Systems · 2011
- Descendant · cites it directly · 3 of its ownK122035 Hepafat ScanResonance Health Analysis Services Pty, Ltd. · 2013
- Descendant · 2 generations on · 2 of its ownK201039 HepaFat-AIResonance Health Analysis Services Pty, Ltd. · 2020
- Descendant · 2 generations on · 0 of its ownK231459 HepaFatSmart (V2.0.0)Resonance Health Analysis Services Pty, Ltd. · 2023
- Descendant · 3 generations on · 0 of its ownK213776 LiverSmartResonance Health Analysis Services Pty, Ltd. · 2021
- Descendant · cites it directly · 0 of its ownK133526 Mdixon-QuantPhilips Medical Systems Nederland B.V. · 2014
Class I recalls in this family
- K041476 GE Signa Excite 1.5T MR System, GE Signa Excite…3 generations back · 2004
- K030874 GE 3.0T Signa Infinity Twinspeed with Excite MR…4 generations back · 2003
- K013636 Signa Infinity MR System with Excite Technology4 generations back · 2002
- K012200 1.5T Infinity Twinspeed MR System5 generations back · 2001
Most influential descendants
Showing 5 of 5 · See all- K122035Hepafat ScanResonance Health Analysis Services Pty, Ltd. · 2013 · cites it directly3descendants
- K201039HepaFat-AIResonance Health Analysis Services Pty, Ltd. · 2020 · 2 generations on2descendants
- K231459HepaFatSmart (V2.0.0)Resonance Health Analysis Services Pty, Ltd. · 2023 · 2 generations on0descendants
- K213776LiverSmartResonance Health Analysis Services Pty, Ltd. · 2021 · 3 generations on0descendants
- K133526Mdixon-QuantPhilips Medical Systems Nederland B.V. · 2014 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K962061 | Magnetic Resonance Diagnostic System | GE Medical Systems | 1996 | 2 |
| −5 | K012200 | 1.5T Infinity Twinspeed MR System | GE Medical Systems | 2001 | Class I |
| −4 | K013636 | Signa Infinity MR System with Excite Technology | GE Medical Systems | 2002 | Class I |
| −3 | K041476 | GE Signa Excite 1.5T MR System, GE Signa Excite 3.0T MR System | Ge Medical Systems, LLC | 2004 | Class I |
| −2 | K052293 | GE 1.5T and 3.0T Signa HDX MR System | Ge Medical Systems, LLC | 2005 | 21 |
| −1 | K072998 | Ideal Software Option for GE MR Scanners | Ge Medical Systems, LLC | 2007 | — |
| 0 (this device) | K103411 | Ideal IQ Software Option | GE Medical Systems | 2011 | — |
| +1 | K122035 | Hepafat Scan | Resonance Health Analysis Services Pty, Ltd. | 2013 | — |
| +2 | K201039 | HepaFat-AI | Resonance Health Analysis Services Pty, Ltd. | 2020 | — |
| +2 | K231459 | HepaFatSmart (V2.0.0) | Resonance Health Analysis Services Pty, Ltd. | 2023 | — |
| +3 | K213776 | LiverSmart | Resonance Health Analysis Services Pty, Ltd. | 2021 | — |
| +1 | K133526 | Mdixon-Quant | Philips Medical Systems Nederland B.V. | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2001 | 2 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 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? (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 |
|---|---|---|---|
| * | K072998 | Ideal Software Option for GE MR ScannersSummary page 1….F.R. 892.1000 Magnetic Resonance Diagnostic Device Product Code: LNH Predicate Device(s): IDEAL Software Option, K072998 Device Description: IDEAL IQ is a software application offered as an option for GE MR s… | 2007 |
What descends from it? (5)
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 · 3 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 · 4 generations back · ◆ in the 2003 ancestors bar of FIG. 11 Class I recall
- K013636Signa Infinity MR System with Excite TechnologyGE Medical Systems · 2002 · 4 generations back · ◆ on the line of descent in FIG. 11 Class I recall
- K0122001.5T Infinity Twinspeed MR SystemGE Medical Systems · 2001 · 5 generations back · ◆ on the line of descent in FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 15 years and passes through 2 companies; a new generation was cleared every 2.4 years on median.
- 7 of the 12 ancestors have a recall of any class; 4 have a Class I recall.
- Of its descendants, K122035 (Resonance Health Analysis Services Pty, Ltd., 2013) has gone furthest, with 3 descendants of its own.
- 1 other device also cites its predicate K072998.
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. 2011, 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?
IDEAL [Q is a software option intended for use on GE MR systems. IDEAL IQ is capable of producing transverse, sagittal, coronal, and oblique images of internal structures of the body, including but not limited to, the musculoskeletal, breast, abdominal, and neurological systems. Specific anatomical regions that may be imaged include the abdomen, breast, spine, joints, and extremities. IDEAL IQ is an acquisition and reconstruction technique that…
Read the full statement (168 words)
IDEAL [Q is a software option intended for use on GE MR systems. IDEAL IQ is capable of producing transverse, sagittal, coronal, and oblique images of internal structures of the body, including but not limited to, the musculoskeletal, breast, abdominal, and neurological systems. Specific anatomical regions that may be imaged include the abdomen, breast, spine, joints, and extremities.
IDEAL IQ is an acquisition and reconstruction technique that simultaneously obtains independent images of hydrogen nuclei that resonate at different frequencies to provide separation of water and triglyceride fat. IDEAL IQ generates images of separated water and triglyceride fat, relative triglyceride fat fraction map, and tissue transverse magnetization relaxation. In the liver, the relative triglyceride fat fraction map is quantitative; it reflects the proton density (number of protons per unit volume) of triglyceride fat, divided by the sum of the proton density of triglyceride fat and the proton density of water, on a voxel-by-voxel basis.
When interpreted by a trained physician, these images provide information that can aid in diagnosis.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K103411 · printed Nov 6, 2026
Cite this page
510(k) Report. “K103411: Ideal IQ Software Option.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K103411
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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