510(k) · Cleared

Cleared

Ideal Software Option for GE MR Scanners

K072998510(k) TraditionalCleared Nov 1, 20078-day reviewClass II21 CFR 892.1000

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Ge Medical Systems, LLC · LNH System, Nuclear Magnetic Resonance Imaging

Cleared on Nov 1, 2007 as substantially equivalent to K052293 (Ge Medical Systems, LLC, 2005) after an 8-day review. Its family tree reaches back 5 generations to 1996. 4 of the 20 devices in its family, counting itself, have a Class I recall. 8 later devices descend from it.

Decided: Nov 1, 2007
Review: 8 days
Class: Class II
Product code: LNH
Recalls: None
Predicates: 1

Its longest line of descent runs back 5 generations to K962061 (1996). 11 ancestors in all. 8 later devices descend from it, 2 citing it directly. 4 of the 20 devices in this family, counting this one, have a Class I recall.

By dateBy generation

Root · 5 generations backK962061 Magnetic Resonance Diagnostic SystemGE Medical Systems · 1996 · Recalled
4 generations backK012200 1.5T Infinity Twinspeed MR SystemGE Medical Systems · 2001 · Recalled (Class I)
3 generations backK013636 Signa Infinity MR System with Excite TechnologyGE Medical Systems · 2002 · Recalled (Class I)
2 generations backK041476 GE Signa Excite 1.5T MR System, GE Signa Excite 3.0T MR SystemGe Medical Systems, LLC · 2004 · Recalled (Class I)
1 generation backK052293 GE 1.5T and 3.0T Signa HDX MR SystemGe Medical Systems, LLC · 2005 · Recalled
This deviceK072998 Ideal Software Option for GE MR ScannersGe Medical Systems, LLC · 2007
Descendant · cites it directly · 5 of its ownK103411 Ideal IQ Software OptionGE Medical Systems · 2011
Descendant · 2 generations on · 3 of its ownK122035 Hepafat ScanResonance Health Analysis Services Pty, Ltd. · 2013
Descendant · 3 generations on · 2 of its ownK201039 HepaFat-AIResonance Health Analysis Services Pty, Ltd. · 2020
Descendant · cites it directly · 1 of its ownK102344 Mdixon Software Option for Intera 1.5T, Achieva 1.5T & Achieva 3.0T…Philips Medical Systems Nederland B.V. · 2010
Descendant · 3 generations on · 0 of its ownK231459 HepaFatSmart (V2.0.0)Resonance Health Analysis Services Pty, Ltd. · 2023

Showing 5 of 8 descendants. See all descendants

Descendants cleared per year

2010high 1 (2010) · low 0 (2012)2026

Class I recalls in this family

K041476 GE Signa Excite 1.5T MR System, GE Signa Excite…2 generations back · 2004
K030874 GE 3.0T Signa Infinity Twinspeed with Excite MR…3 generations back · 2003
K013636 Signa Infinity MR System with Excite Technology3 generations back · 2002
K012200 1.5T Infinity Twinspeed MR System4 generations back · 2001

Most influential descendants

Showing 5 of 8 · See all

K103411Ideal IQ Software OptionGE Medical Systems · 2011 · cites it directly5descendants
K122035Hepafat ScanResonance Health Analysis Services Pty, Ltd. · 2013 · 2 generations on3descendants
K201039HepaFat-AIResonance Health Analysis Services Pty, Ltd. · 2020 · 3 generations on2descendants
K102344Mdixon Software Option for Intera 1.5T, Achieva 1.5T & Achieva 3.0T MR SystemsPhilips Medical Systems Nederland B.V. · 2010 · cites it directly1descendant
K231459HepaFatSmart (V2.0.0)Resonance Health Analysis Services Pty, Ltd. · 2023 · 3 generations on0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−5	K962061	Magnetic Resonance Diagnostic System	GE Medical Systems	1996	2
−4	K012200	1.5T Infinity Twinspeed MR System	GE Medical Systems	2001	Class I
−3	K013636	Signa Infinity MR System with Excite Technology	GE Medical Systems	2002	Class I
−2	K041476	GE Signa Excite 1.5T MR System, GE Signa Excite 3.0T MR System	Ge Medical Systems, LLC	2004	Class I
−1	K052293	GE 1.5T and 3.0T Signa HDX MR System	Ge Medical Systems, LLC	2005	21
0 (this device)	K072998	Ideal Software Option for GE MR Scanners	Ge Medical Systems, LLC	2007	—
+1	K103411	Ideal IQ Software Option	GE Medical Systems	2011	—
+2	K122035	Hepafat Scan	Resonance Health Analysis Services Pty, Ltd.	2013	—
+3	K201039	HepaFat-AI	Resonance Health Analysis Services Pty, Ltd.	2020	—
+1	K102344	Mdixon Software Option for Intera 1.5T, Achieva 1.5T & Achieva 3.0T MR Systems	Philips Medical Systems Nederland B.V.	2010	—
+3	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
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
2010	1	0
2011	1	0
2013	1	0
2014	1	0
2015	1	0
2020	1	0
2021	1	0
2023	1	0

FIG. 1 — Lineage of K072998, 1996–2023Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

Get a 510(k) 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	Applicant	Decided	Recalls
*	K052293	GE 1.5T and 3.0T Signa HDX MR System Summary page 1 …(21 CFR 892.1000, Product Code LNH) Predicate Device(s): GE 1.5T and 3.OT Signa HDx MR Systems K052293 - Device Description: The IDEAL Software Option is a software only product for use on GE Signa MR scanners. To…	Ge Medical Systems, LLC	2005	21

Also cleared against K052293: 6 other devices →

What descends from it? (8)

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K103411	Ideal IQ Software Option	GE Medical Systems	2011	5
K102344	Mdixon Software Option for Intera 1.5T, Achieva 1.5T & Achieva 3.0T MR Systems	Philips Medical Systems Nederland B.V.	2010	1

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 · 2 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 · 3 generations back · ◆ in the 2003 ancestors bar of FIG. 11 Class I recall
K013636Signa Infinity MR System with Excite TechnologyGE Medical Systems · 2002 · 3 generations back · ◆ on the line of descent in FIG. 11 Class I recall
K0122001.5T Infinity Twinspeed MR SystemGE Medical Systems · 2001 · 4 generations back · ◆ on the line of descent in FIG. 11 Class I recall

What does this lineage say?

The line of descent spans 11 years and passes through 2 companies; a new generation was cleared every 2.1 years on median.
7 of the 11 ancestors have a recall of any class; 4 have a Class I recall.
Of its descendants, K103411 (GE Medical Systems, 2011) has gone furthest, with 5 descendants of its own.
6 other devices also cite its predicate K052293.

How does its category compare?

All LNH devices

LNH System, Nuclear Magnetic Resonance Imaging: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.

FDA decisions per year · LNH

26in 2025

2007high 32 (2020) · low 12 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LNH

122in 2025

2007high 140 (2015) · low 35 (2007)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · LNH

8in 2025

2007high 71 (2018) · low 0 (2017)2026

Class I (8 since 2007) Class II/III not classified

Adverse event reports per year · LNH

1,263in 2025

2007high 1,263 (2025) · low 84 (2021)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 is a software option intended for use on GE Signa MR systems. It is indicated for magnetic resonance imaging of the musculoskeletal, breast, abdominal, and neurological systems of the body. IDEAL is an acquisition and reconstruction method that simultaneously obtains independent images of nuclei that resonate at different frequencies. IDEAL provides uniform tissue separation, reduces chemical shift artifacts, and minimizes the effects of magnetic…

Read the full statement (192 words)

IDEAL is a software option intended for use on GE Signa MR systems. It is indicated for magnetic resonance imaging of the musculoskeletal, breast, abdominal, and neurological systems of the body.

IDEAL is an acquisition and reconstruction method that simultaneously obtains independent images of nuclei that resonate at different frequencies. IDEAL provides uniform tissue separation, reduces chemical shift artifacts, and minimizes the effects of magnetic field inhomogeneities. The IDEAL method provides higher image quality relative to chemically selective saturation techniques and STIR. Specific tissue for separation may include water and fat.

When used with a GE Signa MR system, IDEAL is capable of producing transverse, sagittal, coronal, and oblique images of internal structures of the body, including, but not limited to, the musculoskeletal, abdominal, and neurological systems. Specific anatomical regions that may be imaged include the cervical-spine, joints, and extremities.

The images reflect the spatial distribution of nuclei exhibiting magnetic resonance. The NMR properties that determine the image appearance are proton density, molecular environment, spin-lattice relaxation time TiT), spin-spin relaxation time (T2), and flow.

When interpreted by a trained physician, these images provide information that can be useful in determining a diagnosis.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K072998 · printed Nov 4, 2026

Cite this page

510(k) Report. “K072998: Ideal Software Option for GE MR Scanners.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K072998

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