510(k) · Cleared
Recalled · Class II · 2018Vantage Titan
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 Jun 1, 2012 as substantially equivalent to K080038 (Toshiba America Medical Systems, In.C, 2008) and 1 other predicate after a 92-day review. Its family tree reaches back 7 generations to 2000. 21 later devices descend from it. It has been recalled 2 times.
- Decided
- Jun 1, 2012
- Review
- 92 days
- Class
- Class II
- Product code
- LNH
- Recalls
- 2
- Predicates
- 2
Its longest line of descent runs back 7 generations to K002531 (2000). 21 later devices descend from it, 3 citing it directly.
- Root · 7 generations backK002531 Excelart with Pianissimo, Model MRT-1501/P3Toshiba America Mri, Inc. · 2000 · Recalled
- 6 generations backK023511 Excelart with Pianissimo XG/AG Spin Edition, Model MRT-1501/P3, P2Toshiba America Medical Systems, In.C · 2002 · Recalled
- 5 generations backK032490 Toshiba Excelart Vantage XGV/Agv Mri Diagnostic System, Models…Toshiba America Medical Systems, In.C · 2003 · Recalled
- 4 generations backK060003 Excelart Vantage ZGVToshibamedical Systems Corporation · 2006 · Recalled
- 3 generations backK063361 Excelart Vantage Atlas, Model MRT-1503Toshiba America Medical Systems, In.C · 2006 · Recalled
- 2 generations backK080038 Vantage Titan, Model MRT-1504/S3Toshiba America Medical Systems, In.C · 2008 · Recalled
- 1 generation backK112003 Vantage Titan HSRToshibamedical Systems Corporation · 2011
- This deviceK120638 Vantage TitanToshibamedical Systems Corporation · 2012
- Descendant · cites it directly · 19 of its ownK141472 Vantage ElanToshiba America Medical Systems, In.C · 2014
- Descendant · cites it directly · 18 of its ownK150427 Vantage Titan 1.5T, V3.1, MRT-1510Toshibamedical Systems Corporation · 2015
- Descendant · 2 generations on · 17 of its ownK160632 Vantage Titan 1.5T, MRT-1510, V3.6 SoftwareToshibamedical Systems Corporation · 2016
- Descendant · 3 generations on · 16 of its ownK170412 Vantage Titan 1.5T, MRT-1510, M-Power GXToshibamedical Systems Corporation · 2017 · Recalled
- Descendant · 4 generations on · 14 of its ownK182282 Vantage Orian 1.5T, MRT-1550, V4.5Canon Medical Systems Corporation · 2018
Showing 5 of 21 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 21 · See all- K141472Vantage ElanToshiba America Medical Systems, In.C · 2014 · cites it directly19descendants
- K150427Vantage Titan 1.5T, V3.1, MRT-1510Toshibamedical Systems Corporation · 2015 · cites it directly18descendants
- K160632Vantage Titan 1.5T, MRT-1510, V3.6 SoftwareToshibamedical Systems Corporation · 2016 · 2 generations on17descendants
- K170412Vantage Titan 1.5T, MRT-1510, M-Power GXToshibamedical Systems Corporation · 2017 · 3 generations on16descendants
- K182282Vantage Orian 1.5T, MRT-1550, V4.5Canon Medical Systems Corporation · 2018 · 4 generations on14descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K002531 | Excelart with Pianissimo, Model MRT-1501/P3 | Toshiba America Mri, Inc. | 2000 | 4 |
| −6 | K023511 | Excelart with Pianissimo XG/AG Spin Edition, Model MRT-1501/P3, P2 | Toshiba America Medical Systems, In.C | 2002 | 2 |
| −5 | K032490 | Toshiba Excelart Vantage XGV/Agv Mri Diagnostic System, Models MRT-1503/P3 and… | Toshiba America Medical Systems, In.C | 2003 | 3 |
| −4 | K060003 | Excelart Vantage ZGV | Toshibamedical Systems Corporation | 2006 | 1 |
| −3 | 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 |
| −1 | K112003 | Vantage Titan HSR | Toshibamedical Systems Corporation | 2011 | — |
| 0 (this device) | K120638 | Vantage Titan | Toshibamedical Systems Corporation | 2012 | — |
| +1 | K141472 | Vantage Elan | Toshiba America Medical Systems, In.C | 2014 | — |
| +1 | K150427 | Vantage Titan 1.5T, V3.1, MRT-1510 | Toshibamedical Systems Corporation | 2015 | — |
| +2 | K160632 | Vantage Titan 1.5T, MRT-1510, V3.6 Software | Toshibamedical Systems Corporation | 2016 | — |
| +3 | K170412 | Vantage Titan 1.5T, MRT-1510, M-Power GX | Toshibamedical Systems Corporation | 2017 | 2 |
| +4 | K182282 | Vantage Orian 1.5T, MRT-1550, V4.5 | Canon Medical Systems Corporation | 2018 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 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? (2)
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…tan (Model MRT-1504/U4) MRI System is comparable to the current 1.5T Vantage Titan MRI System. The Vantage Titan uses the same magnet as the current Vantage Titan (K080038). However, the following modifications have been added: a redefinition of gradient strength, magnet cover and cabinet's config… | 2008 |
| * | K112003 | Vantage Titan HSRSummary page 2…n Vantage Titan Vantage Titan HSR (Subject device) (Predicate, K080038) (Predicate, K112003) a. Static field 1.5T 1.5T 1.5T strength: b. Peak and… | 2011 |
What descends from it? (21)
See all 213 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 |
|---|---|---|---|---|
| May 30, 2018 | Class II | Z-0199-2019 | Device Design | When using respiratory gating with Steady Mode ON in Spin Echo sequence scanning, the SAR (Specific Absorption Rate) value displayed on the console may be lower than the actual SAR value. The actual applied SAR values may exceed the FIRST… |
| Oct 15, 2012 | Class II | Z-1101-2013 | Nonconforming Material/Component | It was found that there is a problem with the LCD monitor used in the console. The LCD monitor may become blank during use. Specifically, the backlight of the LCD monitor may turn off while the system is in use, causing the LCD monitor to… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 12 years and passes through 3 companies; a new generation was cleared every 1.2 years on median.
- 6 of the 7 ancestors have a recall of any class.
- Of its descendants, K141472 (Toshiba America Medical Systems, In.C, 2014) has gone furthest, with 19 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. 2012, 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 JT2)
- 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/K120638 · printed Nov 5, 2026
Cite this page
510(k) Report. “K120638: Vantage Titan.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K120638
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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