510(k) Report

510(k) · Cleared

Cleared

Flexart,Flexart/Hyper, Visart, Visart/Hyper

K983110510(k) TraditionalCleared Feb 25, 1999174-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 Feb 25, 1999 as substantially equivalent to K970573 (Toshiba America Mri, Inc., 1997) and 3 other predicates after a 174-day review. Its family tree reaches back 3 generations to 1990. 2 later devices descend from it.

Decided
Feb 25, 1999
Review
174 days
Class
Class II
Product code
LNH
Recalls
None
Predicates
4

Its longest line of descent runs back 3 generations to K903768 (1990). 8 ancestors in all, the oldest K900889 (1990). 2 later devices descend from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 1998: 1 other ancestor1997: 1 other ancestor1996: 1 other ancestor1994: 1 other ancestor1990: 1 other ancestor2000: 1 descendant cleared2002: 1 descendant clearedK903768 · Magnetic Resonance Device MRT 150A · Toshiba America Mri, Inc. · 1990K961092 · Visart · Toshiba America Medical Systems, In.C · 1996 · recalledK965068 · Magnetic Resonanc Dvce Visart V 3.5 Software · Toshiba America Medical Systems, In.C · 19971990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 3 other ancestors2 generations back: 2 other ancestors 1 generation forward: 1 descendant2 generations forward: 1 descendant K965068 · Magnetic Resonanc Dvce Visart V 3.5 Software · Toshiba America Medical Systems, In.C · 1997K961092 · Visart · Toshiba America Medical Systems, In.C · 1996 · recalledK903768 · Magnetic Resonance Device MRT 150A · Toshiba America Mri, Inc. · 19900
  1. Root · 3 generations backK903768 Magnetic Resonance Device MRT 150AToshiba America Mri, Inc. · 1990
  2. 2 generations backK961092 VisartToshiba America Medical Systems, In.C · 1996 · Recalled
  3. 1 generation backK965068 Magnetic Resonanc Dvce Visart V 3.5 SoftwareToshiba America Medical Systems, In.C · 1997
  4. This deviceK983110 Flexart,Flexart/Hyper, Visart, Visart/HyperToshiba America Mri, Inc. · 1999
  5. Descendant · cites it directly · 1 of its ownK993574 Opart/Prodiga, Opart/Protenza, Opart/ParagonToshiba America Mri, Inc. · 2000
  6. 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 2 of 2 · See all
  • K993574Opart/Prodiga, Opart/Protenza, Opart/ParagonToshiba America Mri, Inc. · 2000 · cites it directly1descendant
  • 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

GenerationNumberDeviceApplicantDecidedRecalls
−3K903768Magnetic Resonance Device MRT 150AToshiba America Mri, Inc.1990—
−2K961092VisartToshiba America Medical Systems, In.C19965
−1K965068Magnetic Resonanc Dvce Visart V 3.5 SoftwareToshiba America Medical Systems, In.C1997—
0 (this device)K983110Flexart,Flexart/Hyper, Visart, Visart/HyperToshiba America Mri, Inc.1999—
+1K993574Opart/Prodiga, Opart/Protenza, Opart/ParagonToshiba America Mri, Inc.2000—
+2K023207Opart (Including Opart Ultra and Ultra Gradient Upgrade Kit)Toshiba America Medical Systems, In.C2002—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199010
199410
199610
199710
199810

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200010
200210
FIG. 1 — Lineage of K983110, 1990–2002Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K213693 MAGNETOM Vida with syngo MR XA50Ascore 23.0 · 18 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (4)

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.

TypeNumberDeviceApplicantDecidedRecalls
*K970573Flexart V3.5 Software
Summary page 2
…, Inc. (TAMI), believes that the Version 4.0 software upgrade for the FLEXART™ and VISART™ systems is substantially equivalent to the software version 3.5 for FLEXART™ (K970573) which was cleared on 7/21/97 and VISART™ (K965068) which was cleared on 7/15/97. TAMI believes that the introduction of cardiac…
Toshiba America Mri, Inc.1997—
*K965068Magnetic Resonanc Dvce Visart V 3.5 Software
Summary page 2
…re upgrade for the FLEXART™ and VISART™ systems is substantially equivalent to the software version 3.5 for FLEXART™ (K970573) which was cleared on 7/21/97 and VISART™ (K965068) which was cleared on 7/15/97. TAMI believes that the introduction of cardiac tagging in V4.0 is substantially equivalent to Card…
Toshiba America Medical Systems, In.C1997—
*K973799Cardiac Tagging Techniques/Magnetom Vision and Magnetom Impact
Summary page 2
…VISART™ (K965068) which was cleared on 7/15/97. TAMI believes that the introduction of cardiac tagging in V4.0 is substantially equivalent to Cardiac Tagging Techniques (K973799) which was cleared on 1/2/98, and CINE Imaging which was cleared with version 3.1 for FLEXART™ (K962138) on 12/23/96. The modific…
Siemens Medical Solutions USA, Inc.1998—
*K962138Flexart V3.1 Software
Summary page 2
…n V4.0 is substantially equivalent to Cardiac Tagging Techniques (K973799) which was cleared on 1/2/98, and CINE Imaging which was cleared with version 3.1 for FLEXART™ (K962138) on 12/23/96. The modifications added to the Version 4.0 software do not raise new questions of safety or efficacy. K3 === Page…
Toshiba America Mri, Inc.1996—

Also cleared against K970573: 1 other device →

What descends from it? (2)

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

NumberDeviceApplicantDecidedDescendants
K993574Opart/Prodiga, Opart/Protenza, Opart/ParagonToshiba America Mri, Inc.20001

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?

  • The line of descent spans 9 years and passes through 2 companies; a new generation was cleared every 1.6 years on median.
  • 2 of the 8 ancestors have a recall of any class.
  • Of its descendants, K993574 (Toshiba America Mri, Inc., 2000) has gone furthest, with 1 descendant of its own.
  • 1 other device also cites its predicate K970573.

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

2007: 122008: 192009: 172010: 122011: 162012: 222013: 192014: 172015: 192016: 202017: 182018: 292019: 262020: 322021: 272022: 302023: 302024: 262025: 262026 (partial year): 24
2007high 32 (2020) · low 12 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LNH

122in 2025

2007: 35 days median2008: 53 days median2009: 70 days median2010: 94 days median2011: 81 days median2012: 89 days median2013: 108 days median2014: 108 days median2015: 140 days median2016: 108 days median2017: 98 days median2018: 128 days median2019: 62 days median2020: 121 days median2021: 87 days median2022: 74 days median2023: 124 days median2024: 104 days median2025: 122 days median2026 (partial year): 126 days median
2007high 140 (2015) · low 35 (2007)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · LNH

8in 2025

2007: 252008: 122009: 72010: 172011: 112012: 52013: 22014: 132015: 12, 2 Class I2016: 12018: 712019: 52020: 42021: 412022: 132023: 10, 1 Class I2024: 42025: 8, 5 Class I2026 (partial year): 43
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

2007: 1142008: 1672009: 1942010: 1652011: 1822012: 1702013: 1072014: 1192015: 1132016: 1352017: 1212018: 1582019: 1582020: 982021: 842022: 1382023: 1592024: 2812025: 1,263
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
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
2007123525114
2008195312167
200917707194
2010129417165
2011168111182
201222895170
2013191082107
20141710813119
20151914012 (2)113
2016201081135
201718980121
20182912871158
201926625158
202032121498
202127874184
2022307413138
20233012410 (1)159
2024261044281
2025261228 (5)1,263
20262412643—

What is it indicated for?

imaging of:

- The Whole Body (including head, abdomen, breast, heart, pelvis, joints, neck, TMJ,

spine, blood vessels, limbs and extremities). [Application terms include MRCP (MR

Cholangiopancreatography), MR Urography, MR Myelography, MR Fluoroscopy, SAS

(Surface Anatomy Scan), Dynamic Scan, Cine Imaging, and Cardiac tagging.]

- Fluid Visualization

- 2D/3D Imaging

- MR Angiography/MR Vascular Imaging

- Blood Oxygenation Level Dependent (BOLD) Imaging

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

Also cleared against K970573

1 other device cites the same predicate.

More from Toshiba America Mri, Inc.

68 FDA decisions under this applicant name. See the company

  • K002531Excelart with Pianissimo, Model MRT-1501/P3Toshiba America Mri, Inc. · 20004 recalls
  • K002522Opart, Model MRT-600Toshiba America Mri, Inc. · 2000
  • K000549Opart, Model MRT-600Toshiba America Mri, Inc. · 2000
  • K993803Excelart with PianissimoToshiba America Mri, Inc. · 20003 recalls
  • K993574Opart/Prodiga, Opart/Protenza, Opart/ParagonToshiba America Mri, Inc. · 2000

Recent decisions in LNH

The LNH category page

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https://510kreport.com/device/K983110 · printed Nov 4, 2026

Cite this page

510(k) Report. “K983110: Flexart,Flexart/Hyper, Visart, Visart/Hyper.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K983110

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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