510(k) · Cleared

Recalled · Class II · 2021

Signa 3.0T Magnetic Resonance System

K022397510(k) SpecialCleared Aug 22, 200230-day reviewClass II21 CFR 892.1000Recalls 1

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

GE Medical Systems · LNH System, Nuclear Magnetic Resonance Imaging

Cleared on Aug 22, 2002 as substantially equivalent to K003613 (GE Medical Systems, 2001) and 1 other predicate after a 30-day review. Its family tree reaches back 1 generation to 1999. 3 of the 107 devices in its family, counting itself, have a Class I recall. 104 later devices descend from it. It has been recalled once.

Decided: Aug 22, 2002
Review: 30 days
Class: Class II
Product code: LNH
Recalls: 1
Predicates: 2

Its longest line of descent runs back 1 generation to K990550 (1999). 2 ancestors in all. 104 later devices descend from it, 2 citing it directly. 3 of the 107 devices in this family, counting this one, have a Class I recall.

By dateBy generation

Root · 1 generation backK990550 3.0T Signa VH/I Magnetic Resonance SystemGe Medical Systems, Inc. · 1999
This deviceK022397 Signa 3.0T Magnetic Resonance SystemGE Medical Systems · 2002
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 104 descendants. See all descendants

Descendants cleared per year

2003high 8 (2020) · low 0 (2006)2026

Class I recalls in this family

K040444 GE Signa 3.0T with Excite MR Systemcites it directly · 2004
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 104 · 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
−1	K990550	3.0T Signa VH/I Magnetic Resonance System	Ge Medical Systems, Inc.	1999	—
0 (this device)	K022397	Signa 3.0T Magnetic Resonance System	GE Medical Systems	2002	—
+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

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
2001	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
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	5	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 K022397, 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? (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	Applicant	Decided	Recalls
*	K003613	3.0.T Signa VH/I (T/R) Body Imaging Coil Summary page 1 …Marketed Device: The Signa’) 3.OT Magnetic Resonance System is substantially equivalent to the currently marketed 3.OT Signa‘”’VH/i transmit/Receive Body Imaging Coil (K003613) and the 3.0 T Signa‘”’VH/i system (K990550). Device Description: The Signa” 3.OT magnetic resonance system is a diagnostic i…	GE Medical Systems	2001	—
*	K990550	3.0T Signa VH/I Magnetic Resonance System Summary page 1 …esonance System is substantially equivalent to the currently marketed 3.OT Signa‘”’VH/i transmit/Receive Body Imaging Coil (K003613) and the 3.0 T Signa‘”’VH/i system (K990550). Device Description: The Signa” 3.OT magnetic resonance system is a diagnostic imaging device that produces transverse, coro…	Ge Medical Systems, Inc.	1999	—

Also cleared against K003613: 2 other devices →

What descends from it? (104)

See all 104

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
K040444	GE Signa 3.0T with Excite MR System Class I	General Electric Co.	2004	2

Has anything in its family been recalled? (3 Class I)

Recalls of this device

Date	Class	Recall	Root cause	Reason
Dec 23, 2021	Class II	Z-0612-2022	Process control	The magnetic resonance systems could potentially have a cryogen ventilation system that does not meet the venting requirements.

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 · Cites it directly · ◆ in the 2004 descendants bar of FIG. 11 Class I recall
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?

None of the 2 ancestors has a recall.
Of its descendants, K030874 (General Electric Co., 2003) has gone furthest, with 100 descendants of its own.
2 other devices also cite its predicate K003613.

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 indications for use for the 3.0T Signa VH/i (Signa 3.0T MR System) Transmit/Receive Body Imaging Coil expands the imaging capability of the 3.0T Signa VH/i MR Imaging System.

The Transmit/Receive Body Imaging Coil is intended for imaging of the Neck, Spine, Abdomeflhorax and the extremities.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K022397 · printed Nov 6, 2026

Cite this page

510(k) Report. “K022397: Signa 3.0T Magnetic Resonance System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K022397

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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