510(k) Report

510(k) · Cleared

Cleared

Opart/Prodiga, Opart/Protenza, Opart/Paragon

K993574510(k) TraditionalCleared Jan 18, 200089-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 Jan 18, 2000 as substantially equivalent to K990260 (Toshiba America Mri, Inc., 1999) and 5 other predicates after an 89-day review. Its family tree reaches back 4 generations to 1990. 1 later device descends from it.

Decided
Jan 18, 2000
Review
89 days
Class
Class II
Product code
LNH
Recalls
None
Predicates
6

Its longest line of descent runs back 4 generations to K903768 (1990). 13 ancestors in all, the oldest K900889 (1990). 1 later device descends from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 1999: 1 other ancestor1996: 2 other ancestors1995: 1 other ancestor1994: 1 other ancestor1998: 2 other ancestors1997: 1 other ancestor1990: 1 other ancestor2002: 1 descendant clearedReference device: K981475 · Opart (MRT-600) Versions 2 Software Upgrade · Toshiba America Mri, Inc. · 1998K903768 · 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 · 1997K983110 · Flexart,Flexart/Hyper, Visart, Visart/Hyper · Toshiba America Mri, Inc. · 19991990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 5 other ancestors2 generations back: 3 other ancestors3 generations back: 1 other ancestor 1 generation forward: 1 descendant K983110 · Flexart,Flexart/Hyper, Visart, Visart/Hyper · Toshiba America Mri, Inc. · 1999K965068 · 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 · 4 generations backK903768 Magnetic Resonance Device MRT 150AToshiba America Mri, Inc. · 1990
  2. 3 generations backK961092 VisartToshiba America Medical Systems, In.C · 1996 · Recalled
  3. 2 generations backK965068 Magnetic Resonanc Dvce Visart V 3.5 SoftwareToshiba America Medical Systems, In.C · 1997
  4. 1 generation backK983110 Flexart,Flexart/Hyper, Visart, Visart/HyperToshiba America Mri, Inc. · 1999
  5. This deviceK993574 Opart/Prodiga, Opart/Protenza, Opart/ParagonToshiba America Mri, Inc. · 2000
  6. Descendant · cites it directly · 0 of its ownK023207 Opart (Including Opart Ultra and Ultra Gradient Upgrade Kit)Toshiba America Medical Systems, In.C · 2002

Most influential descendants

Showing 1 of 1 · See all
  • K023207Opart (Including Opart Ultra and Ultra Gradient Upgrade Kit)Toshiba America Medical Systems, In.C · 2002 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−4K903768Magnetic Resonance Device MRT 150AToshiba America Mri, Inc.1990—
−3K961092VisartToshiba America Medical Systems, In.C19965
−2K965068Magnetic Resonanc Dvce Visart V 3.5 SoftwareToshiba America Medical Systems, In.C1997—
−1K983110Flexart,Flexart/Hyper, Visart, Visart/HyperToshiba America Mri, Inc.1999—
0 (this device)K993574Opart/Prodiga, Opart/Protenza, Opart/ParagonToshiba America Mri, Inc.2000—
+1K023207Opart (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
199510
199620
199710
199820
199910

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200210
FIG. 1 — Lineage of K993574, 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? (6)

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
*K990260OPART
Summary page 1
…additional features available in each subsequent version (see Comparison Table, Appendix B, for detailed description). A brief description follows: v3.0: Based on v2.5 (K990260) with MR Angio and FASE sequences removed v3.1: Based on v2.5 (K990260) v3.2: Based on v2.6 (K990260) v3.3: Based on v2.6 (K990…
Toshiba America Mri, Inc.1999—
*K983110Flexart,Flexart/Hyper, Visart, Visart/Hyper
Summary page 3
…ftware (K981475). Version v3.3 adds Diffusion/Perfusion imaging to the indications for use statement and is substantially equivalent to v4.0 software for FLEXART/VISART (K983110). The Extremity Array coil is substantially equivalent to the currently cleared OPART™ Extremity coil (K962933). The Fluoro monit…
Toshiba America Mri, Inc.1999—
*K962933Opart MRT-600
Summary page 3
…stantially equivalent to v4.0 software for FLEXART/VISART (K983110). The Extremity Array coil is substantially equivalent to the currently cleared OPART™ Extremity coil (K962933). The Fluoro monitor and pointing device is substantially equivalent to the currently cleared OPART™ Fluoro monitor (K962933). Th…
Toshiba America Mri, Inc.1996—
*K962138Flexart V3.1 Software
Summary page 3
…ared OPART™ Fluoro monitor (K962933). The Peripheral Pulse gating unit is substantially equivalent to the VISART/FLEXART Peripheral Pulse gating described in K983110 and K962138. The Motorized Bed is substantially equivalent to the ACCESS™ Compass Bed (K946244/A1) and the FLEXART Bed (K933018/S1). A.4 ==…
Toshiba America Mri, Inc.1996—
*K946244Access (TM) Compass Bed
Summary page 3
…ally equivalent to the VISART/FLEXART Peripheral Pulse gating described in K983110 and K962138. The Motorized Bed is substantially equivalent to the ACCESS™ Compass Bed (K946244/A1) and the FLEXART Bed (K933018/S1). A.4 Public Health Secvice NEALY o ,./(C DEPARTMENT OF HEALTH & HUMAN SER…
Toshiba America Mri, Inc.1995—
*K933018MRT-50GP
Summary page 3
…XART Peripheral Pulse gating described in K983110 and K962138. The Motorized Bed is substantially equivalent to the ACCESS™ Compass Bed (K946244/A1) and the FLEXART Bed (K933018/S1). A.4 Public Health Secvice NEALY o ,./(C DEPARTMENT OF HEALTH & HUMAN SERVICES Q Food and Drug Administrat…
Toshiba America Mri, Inc.19942
†K981475Opart (MRT-600) Versions 2 Software UpgradeToshiba America Mri, Inc.1998—

Also cleared against K990260: 1 other device →

What descends from it? (1)

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

NumberDeviceApplicantDecidedDescendants
K023207Opart (Including Opart Ultra and Ultra Gradient Upgrade Kit)Toshiba America Medical Systems, In.C20020

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 10 years and passes through 2 companies; a new generation was cleared every 1.6 years on median.
  • 2 of the 13 ancestors have a recall of any class.
  • Of its descendants, K023207 (Toshiba America Medical Systems, In.C, 2002) has gone furthest, with 0 descendants of its own.
  • 1 other device also cites its predicate K990260.

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, pelvis, limbs and extremities, spine, neck, TMJ, heart, blood vessels). [Application terms include MRCP (MR Cholangiopancreatography), MR Urography, MR Myelography, MR Fluoroscopy, SAS (Surface Anatomy Scan), Dynamic Scan and Cine Imaging.]

- Fluid Visualization

- 2D/3D Imaging

Additional indications for v3.1, v3.2, & v3.3 (only)

- MR Angiography/MR Vascular Imaging

Additional indication for v3.2 & v3.3 (only)

- Water/Fat Imaging

Additional indication for v3.3 (only)

- Perfusion/Diffusion 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 K990260

1 other device cites the same predicate.

  • K151466MrOpenParamed S.R.L. · 2015

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
  • K991740Opart, Model MRT-600Toshiba America Mri, Inc. · 1999

Recent decisions in LNH

The LNH category page

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https://510kreport.com/device/K993574 · printed Nov 4, 2026

Cite this page

510(k) Report. “K993574: Opart/Prodiga, Opart/Protenza, Opart/Paragon.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K993574

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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