510(k) · Cleared

Cleared

Modification to 3.0T Signa VH/I Magnetic Resonance System

K003575510(k) TraditionalCleared Jan 17, 200158-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 · LNI System, Nuclear Magnetic Resonance Spectroscopic

Cleared on Jan 17, 2001 after a 58-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 2 of the 104 devices in its family, counting itself, have a Class I recall. 103 later devices descend from it.

Decided: Jan 17, 2001
Review: 58 days
Class: Class II
Product code: LNI
Recalls: None
Predicates: 0

103 later devices descend from it, 2 citing it directly. 2 of the 104 devices in this family, counting this one, have a Class I recall.

This deviceK003575 Modification to 3.0T Signa VH/I Magnetic Resonance SystemGE Medical Systems · 2001
Descendant · cites it directly · 100 of its ownK030874 GE 3.0T Signa Infinity Twinspeed with Excite MR SystemGeneral Electric Co. · 2003 · Recalled (Class I)
Descendant · 2 generations on · 99 of its ownK041476 GE Signa Excite 1.5T MR System, GE Signa Excite 3.0T MR SystemGe Medical Systems, LLC · 2004 · Recalled (Class I)
Descendant · 3 generations on · 90 of its ownK052293 GE 1.5T and 3.0T Signa HDX MR SystemGe Medical Systems, LLC · 2005 · Recalled
Descendant · 4 generations on · 70 of its ownK081028 Signa 3.0T MR750 SystemGe Medical Systems, LLC · 2008 · Recalled
Descendant · 4 generations on · 69 of its ownK083147 Discovery MR450Ge Medical Systems, LLC · 2008 · Recalled

Showing 5 of 103 descendants. See all descendants

Descendants cleared per year

2001high 8 (2020) · low 0 (2002)2026

Class I recalls in this family

K030874 GE 3.0T Signa Infinity Twinspeed with Excite MR…cites it directly · 2003
K041476 GE Signa Excite 1.5T MR System, GE Signa Excite…2 generations on · 2004

Most influential descendants

Showing 5 of 103 · See all

K030874GE 3.0T Signa Infinity Twinspeed with Excite MR SystemGeneral Electric Co. · 2003 · cites it directly100descendants
K041476GE Signa Excite 1.5T MR System, GE Signa Excite 3.0T MR SystemGe Medical Systems, LLC · 2004 · 2 generations on99descendants
K052293GE 1.5T and 3.0T Signa HDX MR SystemGe Medical Systems, LLC · 2005 · 3 generations on90descendants
K081028Signa 3.0T MR750 SystemGe Medical Systems, LLC · 2008 · 4 generations on70descendants
K083147Discovery MR450Ge Medical Systems, LLC · 2008 · 4 generations on69descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K003575	Modification to 3.0T Signa VH/I Magnetic Resonance System	GE Medical Systems	2001	—
+1	K030874	GE 3.0T Signa Infinity Twinspeed with Excite MR System	General Electric Co.	2003	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
+3	K052293	GE 1.5T and 3.0T Signa HDX MR System	Ge Medical Systems, LLC	2005	21
+4	K081028	Signa 3.0T MR750 System	Ge Medical Systems, LLC	2008	11
+4	K083147	Discovery MR450	Ge Medical Systems, LLC	2008	10

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2001	1	0
2003	1	1
2004	1	1
2005	3	0
2007	1	0
2008	3	0
2009	2	0
2010	3	0
2011	4	0
2012	5	0
2013	7	0
2014	6	0
2015	6	0
2016	6	0
2017	6	0
2018	3	0
2019	5	0
2020	8	0
2021	5	0
2022	8	0
2023	7	0
2024	2	0
2025	6	0
2026	4	0

FIG. 1 — Lineage of K003575, 2001–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

2 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.

Candidate predicates for a device like this, rankedin the report
Recall history across each candidate’s familyin the report

Get a 510(k) Report

What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (103)

See all 103

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

Number	Device	Applicant	Decided	Descendants
K030874	GE 3.0T Signa Infinity Twinspeed with Excite MR System Class I	General Electric Co.	2003	100
K012970	GE Signa Asset Imaging Option	GE Medical Systems	2001	1

Has anything in its family been recalled? (2 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.

K030874GE 3.0T Signa Infinity Twinspeed with Excite MR SystemGeneral Electric Co. · 2003 · Cites it directly · ◆ in the 2003 descendants bar of FIG. 11 Class I recall
K041476GE Signa Excite 1.5T MR System, GE Signa Excite 3.0T MR SystemGe Medical Systems, LLC · 2004 · 2 generations on · ◆ in the 2004 descendants bar of FIG. 11 Class I recall

What does this lineage say?

Of its descendants, K030874 (General Electric Co., 2003) has gone furthest, with 100 descendants of its own.

How does its category compare?

All LNI devices

LNI System, Nuclear Magnetic Resonance Spectroscopic: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · LNI

1in 2010

2007high 1 (2007) · low 0 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LNI

Too few LNI 510(k)s in any year since 2007 to give a median.

Recalls per year · LNI

12in 2024

2007high 12 (2024) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · LNI

1in 2025

2007high 7 (2012) · low 0 (2007)2025

MAUDE reports naming product code LNI, 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	1	—	0	0
2008	0	—	0	0
2009	0	—	0	0
2010	1	—	0	0
2011	0	—	0	1
2012	0	—	0	7
2013	0	—	0	0
2014	0	—	0	0
2015	0	—	0	1
2016	0	—	0	0
2017	0	—	0	0
2018	0	—	0	0
2019	0	—	0	0
2020	0	—	0	0
2021	0	—	1	0
2022	0	—	0	2
2023	0	—	4	1
2024	0	—	12	1
2025	0	—	0	1
2026	0	—	0	—

https://510kreport.com/device/K003575 · printed Nov 4, 2026

Cite this page

510(k) Report. “K003575: Modification to 3.0T Signa VH/I Magnetic Resonance System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K003575

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Record history

FDA decision record loaded May 2, 2026
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026