510(k) · Cleared

Cleared

Magnetic Resonance Diagnostic System

K972990510(k) TraditionalCleared Feb 5, 1998177-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 Feb 5, 1998 as substantially equivalent to K971055 (Siemens Medical Solutions USA, Inc., 1997) after a 177-day review. Its family tree reaches back 1 generation to 1997. 4 later devices descend from it.

Decided: Feb 5, 1998
Review: 177 days
Class: Class II
Product code: LNH
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K971055 (1997). 4 later devices descend from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK971055 Diffusion Weighted MR Imaging /Magnetom VisionSiemens Medical Solutions USA, Inc. · 1997
This deviceK972990 Magnetic Resonance Diagnostic SystemGE Medical Systems · 1998
Descendant · cites it directly · 3 of its ownK031230 GE Propeller Imaging Option for MriGE Medical Systems · 2003
Descendant · 2 generations on · 1 of its ownK113394 Mavric SLGe Medical Systems, LLC · 2012
Descendant · 3 generations on · 0 of its ownK143253 O-MARPhilips Medical Systems Nederland B.V. · 2015
Descendant · 2 generations on · 0 of its ownK073081 Jet Software for Excelart Vantage Atlas-Z and Atlas-XToshiba America Medical Systems, In.C · 2007

Most influential descendants

Showing 4 of 4 · See all

K031230GE Propeller Imaging Option for MriGE Medical Systems · 2003 · cites it directly3descendants
K113394Mavric SLGe Medical Systems, LLC · 2012 · 2 generations on1descendant
K143253O-MARPhilips Medical Systems Nederland B.V. · 2015 · 3 generations on0descendants
K073081Jet Software for Excelart Vantage Atlas-Z and Atlas-XToshiba America Medical Systems, In.C · 2007 · 2 generations on0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K971055	Diffusion Weighted MR Imaging /Magnetom Vision	Siemens Medical Solutions USA, Inc.	1997	—
0 (this device)	K972990	Magnetic Resonance Diagnostic System	GE Medical Systems	1998	—
+1	K031230	GE Propeller Imaging Option for Mri	GE Medical Systems	2003	—
+2	K113394	Mavric SL	Ge Medical Systems, LLC	2012	—
+3	K143253	O-MAR	Philips Medical Systems Nederland B.V.	2015	—
+2	K073081	Jet Software for Excelart Vantage Atlas-Z and Atlas-X	Toshiba America Medical Systems, In.C	2007	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2003	1	0
2007	1	0
2012	1	0
2015	1	0

FIG. 1 — Lineage of K972990, 1997–2015Source: 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.

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? (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
*	K971055	Diffusion Weighted MR Imaging /Magnetom Vision Summary page 1 …cate The Diffusion Weighted EPI Imaging Option is substantially equivalent to the cufrently marketed Siemens Medical System Diffusion Weighted MR Imaging Option (510k #K971055). Summary of Studies The Diffusion Weighted EPI Imaging Option was evaluated to the IEC 601-2-33 International medical equipmen…	Siemens Medical Solutions USA, Inc.	1997	—

Also cleared against K971055: 2 other devices →

What descends from it? (4)

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

Number	Device	Applicant	Decided	Descendants
K031230	GE Propeller Imaging Option for Mri	GE Medical Systems	2003	3

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?

Its one ancestor has no recall.
Of its descendants, K031230 (GE Medical Systems, 2003) has gone furthest, with 3 descendants of its own.
2 other devices also cite its predicate K971055.

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?

Diffusion Weighted EPI imaging produces magnetic resonance (MR) images whose contrast is dependent on the local diffusion coefficient of water. Diffusion Weighted EPI can be useful in visualizing the apparent loss of diffusion (mobility) by water molecules in brain tissues affected by acute stroke.

Diffusion Weighted EPI is more accurate than conventional MRI pulse sequence (ie Fast FLAIR and Fast Spin Echo) in identifying the occurrence of acute stroke.

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/K972990 · printed Nov 5, 2026

Cite this page

510(k) Report. “K972990: Magnetic Resonance Diagnostic System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K972990

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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