510(k) · Cleared

Cleared

Magnetic Resonance Diagnostic Device

K913475510(k) TraditionalCleared Oct 30, 199186-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 · LNH System, Nuclear Magnetic Resonance Imaging

Cleared on Oct 30, 1991 after an 86-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 2 of the 182 devices in its family, counting itself, have a Class I recall. 181 later devices descend from it.

Decided: Oct 30, 1991
Review: 86 days
Class: Class II
Product code: LNH
Recalls: None
Predicates: 0

181 later devices descend from it, 1 citing it directly. 2 of the 182 devices in this family, counting this one, have a Class I recall.

This deviceK913475 Magnetic Resonance Diagnostic DeviceGE Medical Systems · 1991
Descendant · cites it directly · 180 of its ownK960265 Advantage Windows with Functool OptionGE Medical Systems · 1996 · Recalled
Descendant · 2 generations on · 74 of its ownK971965 Philips EasyvisionPhilips Medical Systems, Inc. · 1998
Descendant · 3 generations on · 48 of its ownK022292 Impax Diagnostic Display Station,Impax Clinical Review Station,Impax…Agfa Corp. · 2002 · Recalled
Descendant · 2 generations on · 38 of its ownK110573 Ready ViewGe Healthcare (Ge Medical Systems Scs) · 2011 · Recalled
Descendant · 2 generations on · 32 of its ownK061429 Dynamic Mri Software Option for C-Scan, E-Scan XQ and E-Scan OperaEsaote, S.p.A. · 2006

Showing 5 of 181 descendants. See all descendants

Descendants cleared per year

1996high 13 (2012) · low 0 (1997)2026

Class I recalls in this family

K143457 NeuroBlate System7 generations on · 2015
K171255 Monteris Medical NeuroBlate System7 generations on · 2017

Most influential descendants

Showing 5 of 181 · See all

K960265Advantage Windows with Functool OptionGE Medical Systems · 1996 · cites it directly180descendants
K971965Philips EasyvisionPhilips Medical Systems, Inc. · 1998 · 2 generations on74descendants
K022292Impax Diagnostic Display Station,Impax Clinical Review Station,Impax for Cardiology…Agfa Corp. · 2002 · 3 generations on48descendants
K110573Ready ViewGe Healthcare (Ge Medical Systems Scs) · 2011 · 2 generations on38descendants
K061429Dynamic Mri Software Option for C-Scan, E-Scan XQ and E-Scan OperaEsaote, S.p.A. · 2006 · 2 generations on32descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K913475	Magnetic Resonance Diagnostic Device	GE Medical Systems	1991	—
+1	K960265	Advantage Windows with Functool Option	GE Medical Systems	1996	1
+2	K971965	Philips Easyvision	Philips Medical Systems, Inc.	1998	—
+3	K022292	Impax Diagnostic Display Station,Impax Clinical Review Station,Impax for…	Agfa Corp.	2002	9
+2	K110573	Ready View	Ge Healthcare (Ge Medical Systems Scs)	2011	1
+2	K061429	Dynamic Mri Software Option for C-Scan, E-Scan XQ and E-Scan Opera	Esaote, S.p.A.	2006	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
1996	1	0
1998	2	0
1999	1	0
2002	1	0
2003	5	0
2004	5	0
2005	7	0
2006	5	0
2007	2	0
2008	6	0
2009	8	0
2010	2	0
2011	7	0
2012	13	0
2013	9	0
2014	5	0
2015	9	1
2016	8	0
2017	9	1
2018	10	0
2019	5	0
2020	8	0
2021	7	0
2022	6	0
2023	6	0
2024	12	0
2025	9	0
2026	13	0

FIG. 1 — Lineage of K913475, 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.

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.

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

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What was it cleared against?

FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

What descends from it? (181)

See all 181

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K960265	Advantage Windows with Functool Option	GE Medical Systems	1996	180

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.

K143457NeuroBlate SystemMonteris Medical, Inc. · 2015 · 7 generations on · ◆ in the 2015 descendants bar of FIG. 11 Class I recall
K171255Monteris Medical NeuroBlate SystemMonteris Medical, Inc. · 2017 · 7 generations on · ◆ in the 2017 descendants bar of FIG. 11 Class I recall

What does this lineage say?

Of its descendants, K960265 (GE Medical Systems, 1996) has gone furthest, with 180 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/K913475 · printed Nov 6, 2026

Cite this page

510(k) Report. “K913475: Magnetic Resonance Diagnostic Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K913475

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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