510(k) · Cleared

Cleared

3.0T Signa VH/I Magnetic Resonance System

K990550510(k) TraditionalCleared May 11, 199978-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, Inc. · LNH System, Nuclear Magnetic Resonance Imaging

Cleared on May 11, 1999 after a 78-day review. The FDA summary names its predicate without a number. 3 of the 108 devices in its family, counting itself, have a Class I recall. 107 later devices descend from it.

Decided: May 11, 1999
Review: 78 days
Class: Class II
Product code: LNH
Recalls: None
Predicates: 0

107 later devices descend from it, 2 citing it directly. 3 of the 108 devices in this family, counting this one, have a Class I recall.

This deviceK990550 3.0T Signa VH/I Magnetic Resonance SystemGe Medical Systems, Inc. · 1999
Descendant · cites it directly · 104 of its ownK022397 Signa 3.0T Magnetic Resonance SystemGE Medical Systems · 2002 · Recalled
Descendant · 2 generations on · 100 of its ownK030874 GE 3.0T Signa Infinity Twinspeed with Excite MR SystemGeneral Electric Co. · 2003 · Recalled (Class I)
Descendant · 3 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 · 4 generations on · 90 of its ownK052293 GE 1.5T and 3.0T Signa HDX MR SystemGe Medical Systems, LLC · 2005 · Recalled
Descendant · 5 generations on · 70 of its ownK081028 Signa 3.0T MR750 SystemGe Medical Systems, LLC · 2008 · Recalled

Showing 5 of 107 descendants. See all descendants

Descendants cleared per year

2001high 8 (2020) · low 0 (2006)2026

Class I recalls in this family

K040444 GE Signa 3.0T with Excite MR System2 generations on · 2004
K030874 GE 3.0T Signa Infinity Twinspeed with Excite MR…2 generations on · 2003
K041476 GE Signa Excite 1.5T MR System, GE Signa Excite…3 generations on · 2004

Most influential descendants

Showing 5 of 107 · See all

K022397Signa 3.0T Magnetic Resonance SystemGE Medical Systems · 2002 · cites it directly104descendants
K030874GE 3.0T Signa Infinity Twinspeed with Excite MR SystemGeneral Electric Co. · 2003 · 2 generations on100descendants
K041476GE Signa Excite 1.5T MR System, GE Signa Excite 3.0T MR SystemGe Medical Systems, LLC · 2004 · 3 generations on99descendants
K052293GE 1.5T and 3.0T Signa HDX MR SystemGe Medical Systems, LLC · 2005 · 4 generations on90descendants
K081028Signa 3.0T MR750 SystemGe Medical Systems, LLC · 2008 · 5 generations on70descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K990550	3.0T Signa VH/I Magnetic Resonance System	Ge Medical Systems, Inc.	1999	—
+1	K022397	Signa 3.0T Magnetic Resonance System	GE Medical Systems	2002	1
+2	K030874	GE 3.0T Signa Infinity Twinspeed with Excite MR System	General Electric Co.	2003	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
+4	K052293	GE 1.5T and 3.0T Signa HDX MR System	Ge Medical Systems, LLC	2005	21
+5	K081028	Signa 3.0T MR750 System	Ge Medical Systems, LLC	2008	11

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2001	1	0
2002	1	0
2003	1	1
2004	2	2
2005	4	0
2007	1	0
2008	4	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 K990550, 1999–2026Source: 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.

3 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
*	—	Signa CV/i Magnetic Resonance System Named without a submission number			—

What descends from it? (107)

See all 107

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

Number	Device	Applicant	Decided	Descendants
K022397	Signa 3.0T Magnetic Resonance System	GE Medical Systems	2002	104
K012970	GE Signa Asset Imaging Option	GE Medical Systems	2001	1

Has anything in its family been recalled? (3 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.

K040444GE Signa 3.0T with Excite MR SystemGeneral Electric Co. · 2004 · 2 generations on · ◆ in the 2004 descendants bar of FIG. 11 Class I recall
K030874GE 3.0T Signa Infinity Twinspeed with Excite MR SystemGeneral Electric Co. · 2003 · 2 generations on · ◆ 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 · 3 generations on · ◆ in the 2004 descendants bar of FIG. 11 Class I recall

What does this lineage say?

Of its descendants, K022397 (GE Medical Systems, 2002) has gone furthest, with 104 descendants of its own.

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.

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?

The Signa VH/i system is a head-only scanner designed to support higher resolution imaging and shorter scan times. The Signa VH/i system is indicated for use as a diagnostic imaging device to produce transverse, sagittal, coronal and oblique images of the internal structures of the head.. The images produced by the Signa VH/i system reflect the spatial distribution of protons (hydrogen nuclei) exhibiting magnetic resonance. The NMR properties that determine the image appearance are proton density, spin-lattice relaxation time (T1), 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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K990550 · printed Nov 4, 2026

Cite this page

510(k) Report. “K990550: 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/K990550

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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