510(k) · Cleared

Cleared

Flexart V3.1 Software

K962138510(k) TraditionalCleared Dec 23, 1996203-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

Toshiba America Mri, Inc. · LNH System, Nuclear Magnetic Resonance Imaging

Cleared on Dec 23, 1996 as substantially equivalent to K933018 (Toshiba America Mri, Inc., 1994) after a 203-day review. Its family tree reaches back 1 generation to 1994. 5 later devices descend from it.

Decided: Dec 23, 1996
Review: 203 days
Class: Class II
Product code: LNH
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K933018 (1994). 5 later devices descend from it, 3 citing it directly.

By dateBy generation

Root · 1 generation backK933018 MRT-50GPToshiba America Mri, Inc. · 1994 · Recalled
This deviceK962138 Flexart V3.1 SoftwareToshiba America Mri, Inc. · 1996
Descendant · cites it directly · 4 of its ownK970573 Flexart V3.5 SoftwareToshiba America Mri, Inc. · 1997
Descendant · cites it directly · 2 of its ownK983110 Flexart,Flexart/Hyper, Visart, Visart/HyperToshiba America Mri, Inc. · 1999
Descendant · cites it directly · 1 of its ownK993574 Opart/Prodiga, Opart/Protenza, Opart/ParagonToshiba America Mri, Inc. · 2000
Descendant · 2 generations on · 0 of its ownK080119 ClearscanEsi, Inc. · 2008
Descendant · 2 generations on · 0 of its ownK023207 Opart (Including Opart Ultra and Ultra Gradient Upgrade Kit)Toshiba America Medical Systems, In.C · 2002

Most influential descendants

Showing 5 of 5 · See all

K970573Flexart V3.5 SoftwareToshiba America Mri, Inc. · 1997 · cites it directly4descendants
K983110Flexart,Flexart/Hyper, Visart, Visart/HyperToshiba America Mri, Inc. · 1999 · cites it directly2descendants
K993574Opart/Prodiga, Opart/Protenza, Opart/ParagonToshiba America Mri, Inc. · 2000 · cites it directly1descendant
K080119ClearscanEsi, Inc. · 2008 · 2 generations on0descendants
K023207Opart (Including Opart Ultra and Ultra Gradient Upgrade Kit)Toshiba America Medical Systems, In.C · 2002 · 2 generations on0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K933018	MRT-50GP	Toshiba America Mri, Inc.	1994	2
0 (this device)	K962138	Flexart V3.1 Software	Toshiba America Mri, Inc.	1996	—
+1	K970573	Flexart V3.5 Software	Toshiba America Mri, Inc.	1997	—
+1	K983110	Flexart,Flexart/Hyper, Visart, Visart/Hyper	Toshiba America Mri, Inc.	1999	—
+1	K993574	Opart/Prodiga, Opart/Protenza, Opart/Paragon	Toshiba America Mri, Inc.	2000	—
+2	K080119	Clearscan	Esi, Inc.	2008	—
+2	K023207	Opart (Including Opart Ultra and Ultra Gradient Upgrade Kit)	Toshiba America Medical Systems, In.C	2002	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
1997	1	0
1999	1	0
2000	1	0
2002	1	0
2008	1	0

FIG. 1 — Lineage of K962138, 1994–2008Source: 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
*	K933018	MRT-50GP Summary page 2 …f hardware and software upgrades that improve the performance of the basic FLEXART™, without introducing new questions of safety or efficacy. The FLEXART™ was cleared by K933018. The increased gradient field strength is less than the IEC standard and that of other manufacturers systems currently on the mar…	Toshiba America Mri, Inc.	1994	2

Also cleared against K933018: 4 other devices →

What descends from it? (5)

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

Number	Device	Applicant	Decided	Descendants
K970573	Flexart V3.5 Software	Toshiba America Mri, Inc.	1997	4
K983110	Flexart,Flexart/Hyper, Visart, Visart/Hyper	Toshiba America Mri, Inc.	1999	2
K993574	Opart/Prodiga, Opart/Protenza, Opart/Paragon	Toshiba America Mri, Inc.	2000	1

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 a recall.
Of its descendants, K970573 (Toshiba America Mri, Inc., 1997) has gone furthest, with 4 descendants of its own.
4 other devices also cite its predicate K933018.

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/K962138 · printed Nov 4, 2026

Cite this page

510(k) Report. “K962138: Flexart V3.1 Software.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K962138

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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