510(k) · Cleared
Recalled · 2005Excelart
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 May 14, 1999 as substantially equivalent to K965068 (Toshiba America Medical Systems, In.C, 1997) after a 78-day review. Its family tree reaches back 3 generations to 1990. 2 later devices descend from it. It has been recalled 5 times.
- Decided
- May 14, 1999
- Review
- 78 days
- Class
- Class II
- Product code
- LNH
- Recalls
- 5
- Predicates
- 1
Its longest line of descent runs back 3 generations to K903768 (1990). 2 later devices descend from it, 1 citing it directly.
- Root · 3 generations backK903768 Magnetic Resonance Device MRT 150AToshiba America Mri, Inc. · 1990
- 2 generations backK961092 VisartToshiba America Medical Systems, In.C · 1996 · Recalled
- 1 generation backK965068 Magnetic Resonanc Dvce Visart V 3.5 SoftwareToshiba America Medical Systems, In.C · 1997
- This deviceK990620 ExcelartToshiba America Mri, Inc. · 1999
- Descendant · cites it directly · 1 of its ownK993803 Excelart with PianissimoToshiba America Mri, Inc. · 2000 · Recalled
- Descendant · 2 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 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K903768 | Magnetic Resonance Device MRT 150A | Toshiba America Mri, Inc. | 1990 | — |
| −2 | K961092 | Visart | Toshiba America Medical Systems, In.C | 1996 | 5 |
| −1 | K965068 | Magnetic Resonanc Dvce Visart V 3.5 Software | Toshiba America Medical Systems, In.C | 1997 | — |
| 0 (this device) | K990620 | Excelart | Toshiba America Mri, Inc. | 1999 | — |
| +1 | K993803 | Excelart with Pianissimo | Toshiba America Mri, Inc. | 2000 | 3 |
| +2 | 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 |
|---|---|---|
| 2000 | 1 | 0 |
| 2002 | 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 |
|---|---|---|---|
| * | K965068 | Magnetic Resonanc Dvce Visart V 3.5 SoftwareSummary page 1…chigi-Ken Japan 324 February 24, 1999 This submission consists of a new Magnetic Resonance Imaging system which is based primarily on the cleared VISART™/Hyper system (K965068) with modifications including a short bore magnet and gantry design. The software used with the EXCELART MRI system is V4 (K98311… | 1997 |
| † | K983110 | Flexart,Flexart/Hyper, Visart, Visart/Hyper | 1999 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K993803 | Excelart with Pianissimo | 2000 | 1 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 25, 2005 | Not classified | Z-0986-05 | Other | Patient information A is displayed with images for patient B. |
| Oct 6, 2004 | Not classified | Z-0270-05 | Other | Software defect causes images to be rotated 180 degrees. |
| Jun 7, 2004 | Not classified | Z-1045-04 | Other | Wrong positioning may cause patient burns. |
| May 6, 2004 | Not classified | Z-0937-04 | Other | Software anomaly. |
| Jan 27, 2004 | Not classified | Z-0546-04 | Other | Software anomally causes image slices to be in incorrect order. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 9 years and passes through 2 companies; a new generation was cleared every 1.8 years on median.
- 1 of the 3 ancestors has a recall of any class.
- Of its descendants, K993803 (Toshiba America Mri, Inc., 2000) has gone furthest, with 1 descendant of its own.
- 2 other devices also cite its predicate K965068.
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, heart, pelvis, joints, neck, TMJ, spine, blood vessels, limbs and extremities). [Application terms include MRCP (MR Cholangiopancreatography), MR Urography, MR Myelography, MR Fluoroscopy, SAS (Surface Anatomy Scan), Dynamic Scan, Cine Imaging, and Cardiac tagging.]
Fluid Visualization
2D/3D Imaging
MR Angiography/MR Vascular Imaging
Blood Oxygenation Level Dependent (BOLD) 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/K990620 · printed Nov 4, 2026
Cite this page
510(k) Report. “K990620: Excelart.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K990620
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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