510(k) · Cleared
ClearedOpart (MRT-600) Versions 2 Software Upgrade
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Toshiba America Mri, Inc. · LNH System, Nuclear Magnetic Resonance Imaging
Cleared on Jul 14, 1998 as substantially equivalent to K962933 (Toshiba America Mri, Inc., 1996) after an 81-day review. Its family tree reaches back 1 generation to 1996. 7 later devices descend from it.
- Decided
- Jul 14, 1998
- Review
- 81 days
- Class
- Class II
- Product code
- LNH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K962933 (1996). 7 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK962933 Opart MRT-600Toshiba America Mri, Inc. · 1996
- This deviceK981475 Opart (MRT-600) Versions 2 Software UpgradeToshiba America Mri, Inc. · 1998
- Descendant · cites it directly · 6 of its ownK990260 OPARTToshiba America Mri, Inc. · 1999
- Descendant · 2 generations on · 3 of its ownK151466 MrOpenParamed S.R.L. · 2015
- Descendant · 3 generations on · 2 of its ownK190524 MRopen 0.5 TAsg Superconductors S.P.A. · 2019
- Descendant · 4 generations on · 1 of its ownK193116 MRopen EVOAsg Superconductors S.P.A. · 2019
- Descendant · 2 generations on · 1 of its ownK993574 Opart/Prodiga, Opart/Protenza, Opart/ParagonToshiba America Mri, Inc. · 2000
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K990260OPARTToshiba America Mri, Inc. · 1999 · cites it directly6descendants
- K151466MrOpenParamed S.R.L. · 2015 · 2 generations on3descendants
- K190524MRopen 0.5 TAsg Superconductors S.P.A. · 2019 · 3 generations on2descendants
- K193116MRopen EVOAsg Superconductors S.P.A. · 2019 · 4 generations on1descendant
- K993574Opart/Prodiga, Opart/Protenza, Opart/ParagonToshiba America Mri, Inc. · 2000 · 2 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K962933 | Opart MRT-600 | Toshiba America Mri, Inc. | 1996 | — |
| 0 (this device) | K981475 | Opart (MRT-600) Versions 2 Software Upgrade | Toshiba America Mri, Inc. | 1998 | — |
| +1 | K990260 | OPART | Toshiba America Mri, Inc. | 1999 | — |
| +2 | K151466 | MrOpen | Paramed S.R.L. | 2015 | — |
| +3 | K190524 | MRopen 0.5 T | Asg Superconductors S.P.A. | 2019 | — |
| +4 | K193116 | MRopen EVO | Asg Superconductors S.P.A. | 2019 | — |
| +2 | K993574 | Opart/Prodiga, Opart/Protenza, Opart/Paragon | Toshiba America Mri, Inc. | 2000 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2002 | 1 | 0 |
| 2015 | 1 | 0 |
| 2019 | 2 | 0 |
| 2024 | 1 | 0 |
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
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 | Decided |
|---|---|---|---|
| * | K962933 | Opart MRT-600Summary page 2…Inc., believes that the Versions 2 (V2) software upgrade for OPART™ system is substantially equivalent to the software which was cleared with the initial OPART™ system (K962933). The modifications added to the Versions 2 (V2) software do not raise new questions of safety or efficacy. This software does no… | 1996 |
What descends from it? (7)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K990260 | OPART | 1999 | 6 |
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?
How does its category compare?
All LNH devicesLNH System, Nuclear Magnetic Resonance Imaging: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LNH
26in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LNH
122in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LNH
8in 2025
Class I (8 since 2007) Class II/III not classified
Adverse event reports per year · LNH
1,263in 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?
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), Dynavic Scan and Cine imaging.]
- Fluid Visualization
- 2D/3D Imaging
- MR Angiography/MR Vascular Imaging
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/K981475 · printed Nov 5, 2026
Cite this page
510(k) Report. “K981475: Opart (MRT-600) Versions 2 Software Upgrade.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K981475
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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