510(k) · Cleared
ClearedVantage Titan HSR
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 Dec 2, 2011 as substantially equivalent to K080038 (Toshiba America Medical Systems, In.C, 2008) after a 142-day review. Its family tree reaches back 6 generations to 2000. 22 later devices descend from it.
- Decided
- Dec 2, 2011
- Review
- 142 days
- Class
- Class II
- Product code
- LNH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K002531 (2000). 22 later devices descend from it, 2 citing it directly.
- Root · 6 generations backK002531 Excelart with Pianissimo, Model MRT-1501/P3Toshiba America Mri, Inc. · 2000 · Recalled
- 5 generations backK023511 Excelart with Pianissimo XG/AG Spin Edition, Model MRT-1501/P3, P2Toshiba America Medical Systems, In.C · 2002 · Recalled
- 4 generations backK032490 Toshiba Excelart Vantage XGV/Agv Mri Diagnostic System, Models…Toshiba America Medical Systems, In.C · 2003 · Recalled
- 3 generations backK060003 Excelart Vantage ZGVToshibamedical Systems Corporation · 2006 · Recalled
- 2 generations backK063361 Excelart Vantage Atlas, Model MRT-1503Toshiba America Medical Systems, In.C · 2006 · Recalled
- 1 generation backK080038 Vantage Titan, Model MRT-1504/S3Toshiba America Medical Systems, In.C · 2008 · Recalled
- This deviceK112003 Vantage Titan HSRToshibamedical Systems Corporation · 2011
- Descendant · cites it directly · 21 of its ownK120638 Vantage TitanToshibamedical Systems Corporation · 2012 · Recalled
- Descendant · 2 generations on · 19 of its ownK141472 Vantage ElanToshiba America Medical Systems, In.C · 2014
- Descendant · 2 generations on · 18 of its ownK150427 Vantage Titan 1.5T, V3.1, MRT-1510Toshibamedical Systems Corporation · 2015
- Descendant · 3 generations on · 17 of its ownK160632 Vantage Titan 1.5T, MRT-1510, V3.6 SoftwareToshibamedical Systems Corporation · 2016
- Descendant · 4 generations on · 16 of its ownK170412 Vantage Titan 1.5T, MRT-1510, M-Power GXToshibamedical Systems Corporation · 2017 · Recalled
Showing 5 of 22 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 22 · See all- K120638Vantage TitanToshibamedical Systems Corporation · 2012 · cites it directly21descendants
- K141472Vantage ElanToshiba America Medical Systems, In.C · 2014 · 2 generations on19descendants
- K150427Vantage Titan 1.5T, V3.1, MRT-1510Toshibamedical Systems Corporation · 2015 · 2 generations on18descendants
- K160632Vantage Titan 1.5T, MRT-1510, V3.6 SoftwareToshibamedical Systems Corporation · 2016 · 3 generations on17descendants
- K170412Vantage Titan 1.5T, MRT-1510, M-Power GXToshibamedical Systems Corporation · 2017 · 4 generations on16descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K002531 | Excelart with Pianissimo, Model MRT-1501/P3 | Toshiba America Mri, Inc. | 2000 | 4 |
| −5 | K023511 | Excelart with Pianissimo XG/AG Spin Edition, Model MRT-1501/P3, P2 | Toshiba America Medical Systems, In.C | 2002 | 2 |
| −4 | K032490 | Toshiba Excelart Vantage XGV/Agv Mri Diagnostic System, Models MRT-1503/P3 and… | Toshiba America Medical Systems, In.C | 2003 | 3 |
| −3 | K060003 | Excelart Vantage ZGV | Toshibamedical Systems Corporation | 2006 | 1 |
| −2 | K063361 | Excelart Vantage Atlas, Model MRT-1503 | Toshiba America Medical Systems, In.C | 2006 | 1 |
| −1 | K080038 | Vantage Titan, Model MRT-1504/S3 | Toshiba America Medical Systems, In.C | 2008 | 2 |
| 0 (this device) | K112003 | Vantage Titan HSR | Toshibamedical Systems Corporation | 2011 | — |
| +1 | K120638 | Vantage Titan | Toshibamedical Systems Corporation | 2012 | 2 |
| +2 | K141472 | Vantage Elan | Toshiba America Medical Systems, In.C | 2014 | — |
| +2 | K150427 | Vantage Titan 1.5T, V3.1, MRT-1510 | Toshibamedical Systems Corporation | 2015 | — |
| +3 | K160632 | Vantage Titan 1.5T, MRT-1510, V3.6 Software | Toshibamedical Systems Corporation | 2016 | — |
| +4 | K170412 | Vantage Titan 1.5T, MRT-1510, M-Power GX | Toshibamedical Systems Corporation | 2017 | 2 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 2 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 2 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 4 | 0 |
| 2021 | 4 | 0 |
| 2022 | 2 | 0 |
| 2024 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 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 |
|---|---|---|---|
| * | K080038 | Vantage Titan, Model MRT-1504/S3Summary page 1…ge Titan HSR (Model MRT-1 504/A5) is a 1.5 Tesla Magnetic Resonance Imaging (MRI) System. The Vantage Titan HSR uses the same magnet as the existing Vantage Titan (K080038). It includes the Toshiba PianiSSimoTM technology (scan noise reduction technology). The design of the gradient coil and the W… | 2008 |
What descends from it? (22)
See all 222 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 11 years and passes through 3 companies; a new generation was cleared every 2.0 years on median.
- 6 of the 6 ancestors have a recall of any class.
- Of its descendants, K120638 (Toshibamedical Systems Corporation, 2012) has gone furthest, with 21 descendants of its own.
- 2 other devices also cite its predicate K080038.
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. 2011, 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?
The MRI system is indicated for use as a diagnostic imaging modality that produces cross-sectional transaxial, coronal, sagittal, and oblique images that display anatomic structures of the head or body. In addition, this system supports non-contrast MRA. MRI (magnetic resonance imaging) images correspond to the spatial distribution of protons (hydrogen nuclei) that exhibit nuclear magnetic resonance (NMR). The NMR properties of body tissues and fluids…
Read the full statement (116 words)
The MRI system is indicated for use as a diagnostic imaging modality that produces cross-sectional transaxial, coronal, sagittal, and oblique images that display anatomic structures of the head or body. In addition, this system supports non-contrast MRA.
MRI (magnetic resonance imaging) images correspond to the spatial distribution of protons (hydrogen nuclei) that exhibit nuclear magnetic resonance (NMR). The NMR properties of body tissues and fluids are:
* Proton density (PD) (also called hydrogen density)
* Spin-lattice relaxation time (Ti)
* Spin-spin relaxation time (T2)
* Flow dynamics
* Chemical shift
Contrast agent use is restricted to the approved drug indications. When interpreted by a trained physician, these images yield information that can be useful in diagnosis.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K112003 · printed Nov 3, 2026
Cite this page
510(k) Report. “K112003: Vantage Titan HSR.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K112003
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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