510(k) · Cleared
ClearedFlexart V3.5 Software
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 21, 1997 as substantially equivalent to K962138 (Toshiba America Mri, Inc., 1996) after a 157-day review. Its family tree reaches back 2 generations to 1994. 4 later devices descend from it.
- Decided
- Jul 21, 1997
- Review
- 157 days
- Class
- Class II
- Product code
- LNH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K933018 (1994). 4 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK933018 MRT-50GPToshiba America Mri, Inc. · 1994 · Recalled
- 1 generation backK962138 Flexart V3.1 SoftwareToshiba America Mri, Inc. · 1996
- This deviceK970573 Flexart V3.5 SoftwareToshiba America Mri, Inc. · 1997
- Descendant · cites it directly · 2 of its ownK983110 Flexart,Flexart/Hyper, Visart, Visart/HyperToshiba America Mri, Inc. · 1999
- Descendant · 2 generations on · 1 of its ownK993574 Opart/Prodiga, Opart/Protenza, Opart/ParagonToshiba America Mri, Inc. · 2000
- Descendant · cites it directly · 0 of its ownK080119 ClearscanEsi, Inc. · 2008
- Descendant · 3 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 4 of 4 · See all- K983110Flexart,Flexart/Hyper, Visart, Visart/HyperToshiba America Mri, Inc. · 1999 · cites it directly2descendants
- K993574Opart/Prodiga, Opart/Protenza, Opart/ParagonToshiba America Mri, Inc. · 2000 · 2 generations on1descendant
- K080119ClearscanEsi, Inc. · 2008 · cites it directly0descendants
- K023207Opart (Including Opart Ultra and Ultra Gradient Upgrade Kit)Toshiba America Medical Systems, In.C · 2002 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K933018 | MRT-50GP | Toshiba America Mri, Inc. | 1994 | 2 |
| −1 | K962138 | Flexart V3.1 Software | Toshiba America Mri, Inc. | 1996 | — |
| 0 (this device) | K970573 | Flexart V3.5 Software | Toshiba America Mri, Inc. | 1997 | — |
| +1 | K983110 | Flexart,Flexart/Hyper, Visart, Visart/Hyper | Toshiba America Mri, Inc. | 1999 | — |
| +2 | K993574 | Opart/Prodiga, Opart/Protenza, Opart/Paragon | Toshiba America Mri, Inc. | 2000 | — |
| +1 | K080119 | Clearscan | Esi, Inc. | 2008 | — |
| +3 | K023207 | Opart (Including Opart Ultra and Ultra Gradient Upgrade Kit) | Toshiba America Medical Systems, In.C | 2002 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2002 | 1 | 0 |
| 2008 | 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 |
|---|---|---|---|
| * | K962138 | Flexart V3.1 SoftwareSummary page 2…ftware upgrades that improve the image quality and performance of the FLEXART™, without introducing new questions of safety or efficacy. The FLEXART™ V3.1 was cleared by K962138. Although the new coils expand the indications for use, they do not change the intended use of the FLEXART™ system. Good Manufact… | 1996 |
What descends from it? (4)
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 2.8 years on median.
- 1 of the 2 ancestors has a recall of any class.
- Of its descendants, K983110 (Toshiba America Mri, Inc., 1999) has gone furthest, with 2 descendants of its own.
- 2 other devices also cite its predicate K962138.
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, joints, spine, neck,
TMJ, heart, blood vessels, and breast). [Application terms include MRCP (MR
Cholangiopancreatography), MR Urography, MR Myelography, 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/K970573 · printed Nov 4, 2026
Cite this page
510(k) Report. “K970573: Flexart V3.5 Software.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K970573
Report an extraction error
Are you the manufacturer?
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