510(k) · Cleared

Cleared

3.0.T Signa VH/I (T/R) Body Imaging Coil

K003613510(k) TraditionalCleared Apr 3, 2001132-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 · MOS Coil, Magnetic Resonance, Specialty

Cleared on Apr 3, 2001 after a 132-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 3 of the 109 devices in its family, counting itself, have a Class I recall. 108 later devices descend from it.

Decided: Apr 3, 2001
Review: 132 days
Class: Class II
Product code: MOS
Recalls: None
Predicates: 0

108 later devices descend from it, 3 citing it directly. 3 of the 109 devices in this family, counting this one, have a Class I recall.

This deviceK003613 3.0.T Signa VH/I (T/R) Body Imaging CoilGE Medical Systems · 2001
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 108 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 108 · 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)	K003613	3.0.T Signa VH/I (T/R) Body Imaging Coil	GE Medical Systems	2001	—
+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	2	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 K003613, 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.

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 MOS device

#1 K253738 3.0T Air 32CH Hnascore 15.2 · 16 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?

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

What descends from it? (108)

See all 108

3 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
K023679	Gore 3.0T Torso Array	W. L. Gore & Associates, Inc.	2002	0

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 MOS devices

MOS Coil, Magnetic Resonance, Specialty: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · MOS

3in 2025

2007high 25 (2011) · low 3 (2019)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MOS

59in 2025

2007high 178 (2019) · low 19 (2007)2026

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

Recalls per year · MOS

13in 2024

2007high 13 (2024) · low 0 (2007)2026

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

Adverse event reports per year · MOS

2in 2025

2007high 13 (2010) · low 2 (2008)2025

MAUDE reports naming product code MOS, 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	16	19	0	4
2008	19	33	2	2
2009	10	43	0	5
2010	16	78	1	13
2011	25	57	0	7
2012	15	49	1	12
2013	7	87	0	10
2014	12	60	0	4
2015	6	58	2	5
2016	11	42	0	7
2017	9	63	0	9
2018	10	30	0	7
2019	3	178	8	8
2020	5	51	1	2
2021	4	41	0	3
2022	11	79	0	5
2023	10	59	0	4
2024	10	39	13	8
2025	3	59	0	2
2026	10	45	0	—

https://510kreport.com/device/K003613 · printed Nov 6, 2026

Cite this page

510(k) Report. “K003613: 3.0.T Signa VH/I (T/R) Body Imaging Coil.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K003613

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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