510(k) · Cleared

Recalled · 2005

Visart

K961092510(k) TraditionalCleared Jun 14, 199687-day reviewClass II21 CFR 892.1000Recalls 5

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

Toshiba America Medical Systems, In.C · LNH System, Nuclear Magnetic Resonance Imaging

Cleared on Jun 14, 1996 as substantially equivalent to K903768 (Toshiba America Mri, Inc., 1990) after an 87-day review. Its family tree reaches back 1 generation to 1990. 6 later devices descend from it. It has been recalled 5 times.

Decided: Jun 14, 1996
Review: 87 days
Class: Class II
Product code: LNH
Recalls: 5
Predicates: 1

Its longest line of descent runs back 1 generation to K903768 (1990). 6 later devices descend from it, 2 citing it directly.

By dateBy generation

Root · 1 generation backK903768 Magnetic Resonance Device MRT 150AToshiba America Mri, Inc. · 1990
This deviceK961092 VisartToshiba America Medical Systems, In.C · 1996
Descendant · cites it directly · 5 of its ownK965068 Magnetic Resonanc Dvce Visart V 3.5 SoftwareToshiba America Medical Systems, In.C · 1997
Descendant · 2 generations on · 2 of its ownK990620 ExcelartToshiba America Mri, Inc. · 1999 · Recalled
Descendant · 2 generations on · 2 of its ownK983110 Flexart,Flexart/Hyper, Visart, Visart/HyperToshiba America Mri, Inc. · 1999
Descendant · cites it directly · 1 of its ownK993803 Excelart with PianissimoToshiba America Mri, Inc. · 2000 · Recalled
Descendant · 3 generations on · 1 of its ownK993574 Opart/Prodiga, Opart/Protenza, Opart/ParagonToshiba America Mri, Inc. · 2000

Showing 5 of 6 descendants. See all descendants

Descendants cleared per year

1997high 2 (1999) · low 0 (1998)2026

Most influential descendants

Showing 5 of 6 · See all

K965068Magnetic Resonanc Dvce Visart V 3.5 SoftwareToshiba America Medical Systems, In.C · 1997 · cites it directly5descendants
K990620ExcelartToshiba America Mri, Inc. · 1999 · 2 generations on2descendants
K983110Flexart,Flexart/Hyper, Visart, Visart/HyperToshiba America Mri, Inc. · 1999 · 2 generations on2descendants
K993803Excelart with PianissimoToshiba America Mri, Inc. · 2000 · cites it directly1descendant
K993574Opart/Prodiga, Opart/Protenza, Opart/ParagonToshiba America Mri, Inc. · 2000 · 3 generations on1descendant

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K903768	Magnetic Resonance Device MRT 150A	Toshiba America Mri, Inc.	1990	—
0 (this device)	K961092	Visart	Toshiba America Medical Systems, In.C	1996	—
+1	K965068	Magnetic Resonanc Dvce Visart V 3.5 Software	Toshiba America Medical Systems, In.C	1997	—
+2	K990620	Excelart	Toshiba America Mri, Inc.	1999	5
+2	K983110	Flexart,Flexart/Hyper, Visart, Visart/Hyper	Toshiba America Mri, Inc.	1999	—
+1	K993803	Excelart with Pianissimo	Toshiba America Mri, Inc.	2000	3
+3	K993574	Opart/Prodiga, Opart/Protenza, Opart/Paragon	Toshiba America Mri, Inc.	2000	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
1997	1	0
1999	2	0
2000	2	0
2002	1	0

FIG. 1 — Lineage of K961092, 1990–2002Source: 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

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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
*	K903768	Magnetic Resonance Device MRT 150A Summary page 2 …ists of hardware and software upgrades that improve the performance of the MRT-150A, without introducing new questions of safety or efficacy. The MRT-150A was cleared by K903768A. The improved computer system architecture and user interface were cleared with the Flexart™ via K933018. The increased gradient…	Toshiba America Mri, Inc.	1990	—
†	K933018	MRT-50GP	Toshiba America Mri, Inc.	1994	2

What descends from it? (6)

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

Number	Device	Applicant	Decided	Descendants
K965068	Magnetic Resonanc Dvce Visart V 3.5 Software	Toshiba America Medical Systems, In.C	1997	5
K993803	Excelart with Pianissimo	Toshiba America Mri, Inc.	2000	1

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

Recalls of this device

Date	Class	Recall	Root cause	Reason
May 25, 2005	Not classified	Z-0986-05	Other	Patient information A is displayed with images for patient B.
Oct 6, 2004	Not classified	Z-0270-05	Other	Software defect causes images to be rotated 180 degrees.
Jun 7, 2004	Not classified	Z-1045-04	Other	Wrong positioning may cause patient burns.
May 6, 2004	Not classified	Z-0937-04	Other	Software anomaly.
Jan 27, 2004	Not classified	Z-0546-04	Other	Software anomally causes image slices to be in incorrect order.

No ancestor or descendant has a Class I recall.

What does this lineage say?

Its one ancestor has no recall.
Of its descendants, K965068 (Toshiba America Medical Systems, In.C, 1997) has gone furthest, with 5 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	—

What is it indicated for?

Anatomical Region: Head, Body, Extremity, Spine, Neck, TMJ, and Heart

Nuclei excited: Hydrogen

Diagnostic Use: Imaging of the whole body (including the head, abdomen, heart, pelvis, spine, blood vessels, limbs and extremities), fluid visualization, 2D/3D Imaging, MR Angiography, MR. Fluoroscopy

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/K961092 · printed Nov 4, 2026

Cite this page

510(k) Report. “K961092: Visart.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K961092

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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