510(k) · Cleared
ClearedOpart MRT-600
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 Oct 25, 1996 after an 88-day review. The FDA summary names its predicate without a number. 10 later devices descend from it.
- Decided
- Oct 25, 1996
- Review
- 88 days
- Class
- Class II
- Product code
- LNH
- Recalls
- None
- Predicates
- 0
10 later devices descend from it, 4 citing it directly.
- This deviceK962933 Opart MRT-600Toshiba America Mri, Inc. · 1996
- Descendant · cites it directly · 7 of its ownK981475 Opart (MRT-600) Versions 2 Software UpgradeToshiba America Mri, Inc. · 1998
- Descendant · 2 generations on · 6 of its ownK990260 OPARTToshiba America Mri, Inc. · 1999
- Descendant · 3 generations on · 3 of its ownK151466 MrOpenParamed S.R.L. · 2015
- Descendant · 4 generations on · 2 of its ownK190524 MRopen 0.5 TAsg Superconductors S.P.A. · 2019
- Descendant · 5 generations on · 1 of its ownK193116 MRopen EVOAsg Superconductors S.P.A. · 2019
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 10 · See all- K981475Opart (MRT-600) Versions 2 Software UpgradeToshiba America Mri, Inc. · 1998 · cites it directly7descendants
- K990260OPARTToshiba America Mri, Inc. · 1999 · 2 generations on6descendants
- K151466MrOpenParamed S.R.L. · 2015 · 3 generations on3descendants
- K190524MRopen 0.5 TAsg Superconductors S.P.A. · 2019 · 4 generations on2descendants
- K193116MRopen EVOAsg Superconductors S.P.A. · 2019 · 5 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K962933 | Opart MRT-600 | Toshiba America Mri, Inc. | 1996 | — |
| +1 | K981475 | Opart (MRT-600) Versions 2 Software Upgrade | Toshiba America Mri, Inc. | 1998 | — |
| +2 | K990260 | OPART | Toshiba America Mri, Inc. | 1999 | — |
| +3 | K151466 | MrOpen | Paramed S.R.L. | 2015 | — |
| +4 | K190524 | MRopen 0.5 T | Asg Superconductors S.P.A. | 2019 | — |
| +5 | K193116 | MRopen EVO | Asg Superconductors S.P.A. | 2019 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 1999 | 3 | 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? (2)
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 |
|---|---|---|---|
| * | — | Flexart™ Named without a submission number | |
| * | — | Access™ Named without a submission number |
What descends from it? (10)
4 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?
- Of its descendants, K981475 (Toshiba America Mri, Inc., 1998) has gone furthest, with 7 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?
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/K962933 · printed Nov 4, 2026
Cite this page
510(k) Report. “K962933: Opart MRT-600.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K962933
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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