510(k) · Cleared
Recalled · Class II · 2020Vantage Titan, Model MRT-1504/S3
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Toshiba America Medical Systems, In.C · LNH System, Nuclear Magnetic Resonance Imaging
Cleared on Jan 22, 2008 as substantially equivalent to K063361 (Toshiba America Medical Systems, In.C, 2006) after a 15-day review. Its family tree reaches back 5 generations to 2000. 61 later devices descend from it. It has been recalled 2 times.
- Decided
- Jan 22, 2008
- Review
- 15 days
- Class
- Class II
- Product code
- LNH
- Recalls
- 2
- Predicates
- 1
Its longest line of descent runs back 5 generations to K002531 (2000). 61 later devices descend from it, 3 citing it directly.
- Root · 5 generations backK002531 Excelart with Pianissimo, Model MRT-1501/P3Toshiba America Mri, Inc. · 2000 · Recalled
- 4 generations backK023511 Excelart with Pianissimo XG/AG Spin Edition, Model MRT-1501/P3, P2Toshiba America Medical Systems, In.C · 2002 · Recalled
- 3 generations backK032490 Toshiba Excelart Vantage XGV/Agv Mri Diagnostic System, Models…Toshiba America Medical Systems, In.C · 2003 · Recalled
- 2 generations backK060003 Excelart Vantage ZGVToshibamedical Systems Corporation · 2006 · Recalled
- 1 generation backK063361 Excelart Vantage Atlas, Model MRT-1503Toshiba America Medical Systems, In.C · 2006 · Recalled
- This deviceK080038 Vantage Titan, Model MRT-1504/S3Toshiba America Medical Systems, In.C · 2008
- Descendant · cites it directly · 56 of its ownK102489 Vantage Titan 3TToshiba Medical Systems Corporation, Japan · 2011 · Recalled
- Descendant · 2 generations on · 53 of its ownK113093 Vantage Titan 3TToshibamedical Systems Corporation · 2012 · Recalled
- Descendant · 3 generations on · 52 of its ownK120487 Vantage Titan 3TToshibamedical Systems Corporation · 2012
- Descendant · 4 generations on · 37 of its ownK132160 Vantage Titan 3TToshibamedical Systems Corporation · 2013
- Descendant · 5 generations on · 36 of its ownK143008 Vantage Titan 3TToshibamedical Systems Corporation · 2015
Showing 5 of 61 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 61 · See all- K102489Vantage Titan 3TToshiba Medical Systems Corporation, Japan · 2011 · cites it directly56descendants
- K113093Vantage Titan 3TToshibamedical Systems Corporation · 2012 · 2 generations on53descendants
- K120487Vantage Titan 3TToshibamedical Systems Corporation · 2012 · 3 generations on52descendants
- K132160Vantage Titan 3TToshibamedical Systems Corporation · 2013 · 4 generations on37descendants
- K143008Vantage Titan 3TToshibamedical Systems Corporation · 2015 · 5 generations on36descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K002531 | Excelart with Pianissimo, Model MRT-1501/P3 | Toshiba America Mri, Inc. | 2000 | 4 |
| −4 | K023511 | Excelart with Pianissimo XG/AG Spin Edition, Model MRT-1501/P3, P2 | Toshiba America Medical Systems, In.C | 2002 | 2 |
| −3 | K032490 | Toshiba Excelart Vantage XGV/Agv Mri Diagnostic System, Models MRT-1503/P3 and… | Toshiba America Medical Systems, In.C | 2003 | 3 |
| −2 | K060003 | Excelart Vantage ZGV | Toshibamedical Systems Corporation | 2006 | 1 |
| −1 | K063361 | Excelart Vantage Atlas, Model MRT-1503 | Toshiba America Medical Systems, In.C | 2006 | 1 |
| 0 (this device) | K080038 | Vantage Titan, Model MRT-1504/S3 | Toshiba America Medical Systems, In.C | 2008 | — |
| +1 | K102489 | Vantage Titan 3T | Toshiba Medical Systems Corporation, Japan | 2011 | 1 |
| +2 | K113093 | Vantage Titan 3T | Toshibamedical Systems Corporation | 2012 | 1 |
| +3 | K120487 | Vantage Titan 3T | Toshibamedical Systems Corporation | 2012 | — |
| +4 | K132160 | Vantage Titan 3T | Toshibamedical Systems Corporation | 2013 | — |
| +5 | K143008 | Vantage Titan 3T | Toshibamedical Systems Corporation | 2015 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 2 | 0 |
| 2012 | 4 | 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 |
|---|---|---|---|
| * | K063361 | Excelart Vantage Atlas, Model MRT-1503Summary page 1…tan provides the maximum field of view of 55 x 55 x 50 cm. The Vantage Titan MRI System is comparable to the current EXCELART Vantage Atlas-X MRI System (K063361), cleared November 21, 2006 with the following modifications. * Gantry bore diameter has been increased from 600mm to 690mm… | 2006 |
What descends from it? (61)
See all 613 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 |
|---|---|---|---|---|
| Apr 13, 2020 | Class II | Z-2245-2020 | Under Investigation by firm | The labeling of the Philips Chest Pneumograph does not include a statement indicating that the product contains natural rubber latex. |
| May 13, 2008 | Class II | Z-2278-2012 | Process design | The status display in the sequence queue window may not change from "Current" to "Done". |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 8 years and passes through 3 companies; a new generation was cleared every 1.2 years on median.
- 5 of the 5 ancestors have a recall of any class.
- Of its descendants, K102489 (Toshiba Medical Systems Corporation, Japan, 2011) has gone furthest, with 56 descendants of its own.
- 4 other devices also cite its predicate K063361.
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. 2008, this device’s year, is highlighted.
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 Scan, Cine Imaging and Cardiac tagging.]
Fluid Visualization
2D / 3D Imaging
MR Angiographl) / 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/K080038 · printed Nov 6, 2026
Cite this page
510(k) Report. “K080038: Vantage Titan, Model MRT-1504/S3.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K080038
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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