510(k) · Cleared
Recalled · Class II · 2012Excelart Vantage ZGV
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Toshibamedical Systems Corporation · LNH System, Nuclear Magnetic Resonance Imaging
Cleared on Jan 18, 2006 as substantially equivalent to K032490 (Toshiba America Medical Systems, In.C, 2003) after a 15-day review. Its family tree reaches back 3 generations to 2000. 69 later devices descend from it. It has been recalled once.
- Decided
- Jan 18, 2006
- Review
- 15 days
- Class
- Class II
- Product code
- LNH
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 3 generations to K002531 (2000). 69 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK002531 Excelart with Pianissimo, Model MRT-1501/P3Toshiba America Mri, Inc. · 2000 · Recalled
- 2 generations backK023511 Excelart with Pianissimo XG/AG Spin Edition, Model MRT-1501/P3, P2Toshiba America Medical Systems, In.C · 2002 · Recalled
- 1 generation backK032490 Toshiba Excelart Vantage XGV/Agv Mri Diagnostic System, Models…Toshiba America Medical Systems, In.C · 2003 · Recalled
- This deviceK060003 Excelart Vantage ZGVToshibamedical Systems Corporation · 2006
- Descendant · cites it directly · 68 of its ownK063361 Excelart Vantage Atlas, Model MRT-1503Toshiba America Medical Systems, In.C · 2006 · Recalled
- Descendant · 2 generations on · 61 of its ownK080038 Vantage Titan, Model MRT-1504/S3Toshiba America Medical Systems, In.C · 2008 · Recalled
- Descendant · 3 generations on · 56 of its ownK102489 Vantage Titan 3TToshiba Medical Systems Corporation, Japan · 2011 · Recalled
- Descendant · 4 generations on · 53 of its ownK113093 Vantage Titan 3TToshibamedical Systems Corporation · 2012 · Recalled
- Descendant · 5 generations on · 52 of its ownK120487 Vantage Titan 3TToshibamedical Systems Corporation · 2012
Showing 5 of 69 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 69 · See all- K063361Excelart Vantage Atlas, Model MRT-1503Toshiba America Medical Systems, In.C · 2006 · cites it directly68descendants
- K080038Vantage Titan, Model MRT-1504/S3Toshiba America Medical Systems, In.C · 2008 · 2 generations on61descendants
- K102489Vantage Titan 3TToshiba Medical Systems Corporation, Japan · 2011 · 3 generations on56descendants
- K113093Vantage Titan 3TToshibamedical Systems Corporation · 2012 · 4 generations on53descendants
- K120487Vantage Titan 3TToshibamedical Systems Corporation · 2012 · 5 generations on52descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K002531 | Excelart with Pianissimo, Model MRT-1501/P3 | Toshiba America Mri, Inc. | 2000 | 4 |
| −2 | K023511 | Excelart with Pianissimo XG/AG Spin Edition, Model MRT-1501/P3, P2 | Toshiba America Medical Systems, In.C | 2002 | 2 |
| −1 | K032490 | Toshiba Excelart Vantage XGV/Agv Mri Diagnostic System, Models MRT-1503/P3 and… | Toshiba America Medical Systems, In.C | 2003 | 3 |
| 0 (this device) | K060003 | Excelart Vantage ZGV | Toshibamedical Systems Corporation | 2006 | — |
| +1 | K063361 | Excelart Vantage Atlas, Model MRT-1503 | Toshiba America Medical Systems, In.C | 2006 | 1 |
| +2 | K080038 | Vantage Titan, Model MRT-1504/S3 | Toshiba America Medical Systems, In.C | 2008 | 2 |
| +3 | K102489 | Vantage Titan 3T | Toshiba Medical Systems Corporation, Japan | 2011 | 1 |
| +4 | K113093 | Vantage Titan 3T | Toshibamedical Systems Corporation | 2012 | 1 |
| +5 | K120487 | Vantage Titan 3T | Toshibamedical Systems Corporation | 2012 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 2 | 0 |
| 2011 | 4 | 0 |
| 2012 | 6 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 4 | 0 |
| 2016 | 2 | 0 |
| 2017 | 3 | 0 |
| 2018 | 7 | 0 |
| 2019 | 4 | 0 |
| 2020 | 7 | 0 |
| 2021 | 9 | 0 |
| 2022 | 5 | 0 |
| 2023 | 2 | 0 |
| 2024 | 5 | 0 |
| 2025 | 3 | 0 |
| 2026 | 2 | 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 |
|---|---|---|---|
| * | K032490 | Toshiba Excelart Vantage XGV/Agv Mri Diagnostic System, Models MRT-1503/P3 and MRT-1503/P2Summary page 2…age TM XGV/AGV (No Vantage TM ZGV changes from the previous submission, K032490) a. Static field strength: 1.5 T Same b. Peak and A-weighted… | 2003 |
What descends from it? (69)
See all 692 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Feb 21, 2012 | Class II | Z-2315-2012 | Component change control | The firm recalled due to a potentail problem with the position of the hold in the lug teminals on the power cables connected to the terminal blocks on the gradient coil. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 6 years and passes through 3 companies; a new generation was cleared every 2.0 years on median.
- 3 of the 3 ancestors have a recall of any class.
- Of its descendants, K063361 (Toshiba America Medical Systems, In.C, 2006) has gone furthest, with 68 descendants of its own.
- 1 other device also cites its predicate K032490.
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 Cisternography, MR Urography, MR Myelography, MR Fluoroscopy, SAS (Surface Anatomy Scan), Dynamic ScanCine Imaging and Cardiac tagging.]
• Fluid Visualization
• 2D/3D Imaging
• MR Angiography / MR Vascular Imaging
• Blood Oxygenation Level Dependent (BOLD) imaging
• Perfusion / Diffusion Imaging
• Proton Spectroscopy
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K060003 · printed Nov 4, 2026
Cite this page
510(k) Report. “K060003: Excelart Vantage ZGV.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K060003
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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