510(k) · Cleared

Cleared

Magnetic Resonance Diagnostic Accessory

K911806510(k) TraditionalCleared Jun 28, 199166-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

General Electric Co. · LNH System, Nuclear Magnetic Resonance Imaging

Cleared on Jun 28, 1991 after a 66-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 68 later devices descend from it.

Decided: Jun 28, 1991
Review: 66 days
Class: Class II
Product code: LNH
Recalls: None
Predicates: 0

68 later devices descend from it, 3 citing it directly.

This deviceK911806 Magnetic Resonance Diagnostic AccessoryGeneral Electric Co. · 1991
Descendant · cites it directly · 65 of its ownK980157 Premier 7000 CTL Spine CoilUsa Instruments, Inc. · 1998
Descendant · 2 generations on · 51 of its ownK994345 Magna 5000 Phased Array CTL Spine CoilUsa Instruments, Inc. · 2000
Descendant · 3 generations on · 45 of its ownK042236 G-SCANEsaote, S.p.A. · 2004
Descendant · 4 generations on · 43 of its ownK060956 G-Scan-Model 9800020000, E-Scan Model 9800010000 and E-Scan…Esaote, S.p.A. · 2006
Descendant · 3 generations on · 34 of its ownK063207 S-Scan Mri SystemEsaote, S.p.A. · 2006

Showing 5 of 68 descendants. See all descendants

Descendants cleared per year

1996high 7 (2003) · low 0 (1997)2026

Most influential descendants

Showing 5 of 68 · See all

K980157Premier 7000 CTL Spine CoilUsa Instruments, Inc. · 1998 · cites it directly65descendants
K994345Magna 5000 Phased Array CTL Spine CoilUsa Instruments, Inc. · 2000 · 2 generations on51descendants
K042236G-SCANEsaote, S.p.A. · 2004 · 3 generations on45descendants
K060956G-Scan-Model 9800020000, E-Scan Model 9800010000 and E-Scan…Esaote, S.p.A. · 2006 · 4 generations on43descendants
K063207S-Scan Mri SystemEsaote, S.p.A. · 2006 · 3 generations on34descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K911806	Magnetic Resonance Diagnostic Accessory	General Electric Co.	1991	—
+1	K980157	Premier 7000 CTL Spine Coil	Usa Instruments, Inc.	1998	—
+2	K994345	Magna 5000 Phased Array CTL Spine Coil	Usa Instruments, Inc.	2000	—
+3	K042236	G-SCAN	Esaote, S.p.A.	2004	—
+4	K060956	G-Scan-Model 9800020000, E-Scan Model 9800010000 and E-Scan…	Esaote, S.p.A.	2006	—
+3	K063207	S-Scan Mri System	Esaote, S.p.A.	2006	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
1996	1	0
1998	2	0
2000	1	0
2001	1	0
2002	5	0
2003	7	0
2004	2	0
2005	1	0
2006	4	0
2007	1	0
2008	5	0
2009	2	0
2010	2	0
2011	5	0
2012	7	0
2013	3	0
2015	4	0
2016	3	0
2017	1	0
2019	4	0
2021	1	0
2022	1	0
2024	2	0
2026	3	0

FIG. 1 — Lineage of K911806, 1991–2026Source: 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.

Planning a device in LNH? 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?

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

What descends from it? (68)

See all 68

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

Number	Device	Applicant	Decided	Descendants
K980157	Premier 7000 CTL Spine Coil	Usa Instruments, Inc.	1998	65
K023679	Gore 3.0T Torso Array	W. L. Gore & Associates, Inc.	2002	0
K961628	Mini Flex Coil	W. L. Gore & Associates, Inc.	1996	0

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

Of its descendants, K980157 (Usa Instruments, Inc., 1998) has gone furthest, with 65 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	—

https://510kreport.com/device/K911806 · printed Nov 4, 2026

Cite this page

510(k) Report. “K911806: Magnetic Resonance Diagnostic Accessory.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K911806

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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