510(k) · Cleared
ClearedOPART
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 Apr 15, 1999 as substantially equivalent to K981475 (Toshiba America Mri, Inc., 1998) after a 78-day review. Its family tree reaches back 2 generations to 1996. 6 later devices descend from it.
- Decided
- Apr 15, 1999
- Review
- 78 days
- Class
- Class II
- Product code
- LNH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K962933 (1996). 6 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK962933 Opart MRT-600Toshiba America Mri, Inc. · 1996
- 1 generation backK981475 Opart (MRT-600) Versions 2 Software UpgradeToshiba America Mri, Inc. · 1998
- This deviceK990260 OPARTToshiba America Mri, Inc. · 1999
- Descendant · cites it directly · 3 of its ownK151466 MrOpenParamed S.R.L. · 2015
- Descendant · 2 generations on · 2 of its ownK190524 MRopen 0.5 TAsg Superconductors S.P.A. · 2019
- Descendant · 3 generations on · 1 of its ownK193116 MRopen EVOAsg Superconductors S.P.A. · 2019
- Descendant · cites it directly · 1 of its ownK993574 Opart/Prodiga, Opart/Protenza, Opart/ParagonToshiba America Mri, Inc. · 2000
- Descendant · 4 generations on · 0 of its ownK242258 MROpen Evo (03-2000-00); MROpen Evo (03-4000-00)Asg Superconductors S.P.A. · 2024
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K151466MrOpenParamed S.R.L. · 2015 · cites it directly3descendants
- K190524MRopen 0.5 TAsg Superconductors S.P.A. · 2019 · 2 generations on2descendants
- K193116MRopen EVOAsg Superconductors S.P.A. · 2019 · 3 generations on1descendant
- K993574Opart/Prodiga, Opart/Protenza, Opart/ParagonToshiba America Mri, Inc. · 2000 · cites it directly1descendant
- K242258MROpen Evo (03-2000-00); MROpen Evo (03-4000-00)Asg Superconductors S.P.A. · 2024 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K962933 | Opart MRT-600 | Toshiba America Mri, Inc. | 1996 | — |
| −1 | K981475 | Opart (MRT-600) Versions 2 Software Upgrade | Toshiba America Mri, Inc. | 1998 | — |
| 0 (this device) | K990260 | OPART | Toshiba America Mri, Inc. | 1999 | — |
| +1 | K151466 | MrOpen | Paramed S.R.L. | 2015 | — |
| +2 | K190524 | MRopen 0.5 T | Asg Superconductors S.P.A. | 2019 | — |
| +3 | K193116 | MRopen EVO | Asg Superconductors S.P.A. | 2019 | — |
| +1 | K993574 | Opart/Prodiga, Opart/Protenza, Opart/Paragon | Toshiba America Mri, Inc. | 2000 | — |
| +4 | K242258 | MROpen Evo (03-2000-00); MROpen Evo (03-4000-00) | Asg Superconductors S.P.A. | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K981475 | Opart (MRT-600) Versions 2 Software UpgradeSummary page 2…oftware does not introduce any new indications for use from those cleared in the Premarket Notifications for OPART™ version 2 diagnostic resonance systems 510(k) number K981475. Page A 3 RS Lot PRl P ) . ,_/C DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service k‘""} Food and Dru… | 1998 |
What descends from it? (6)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 3 years and passes through 1 company; a new generation was cleared every 1.7 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K151466 (Paramed S.R.L., 2015) has gone furthest, with 3 descendants of its own.
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, breast, 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
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/K990260 · printed Nov 4, 2026
Cite this page
510(k) Report. “K990260: OPART.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K990260
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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