510(k) · Cleared
Recalled · Class II · 2012Vantage Titan 3T
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 13, 2012 as substantially equivalent to K102489 (Toshiba Medical Systems Corporation, Japan, 2011) after an 86-day review. Its family tree reaches back 7 generations to 2000. 53 later devices descend from it. It has been recalled once.
- Decided
- Jan 13, 2012
- Review
- 86 days
- Class
- Class II
- Product code
- LNH
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 7 generations to K002531 (2000). 53 later devices descend from it, 1 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 backK102489 Vantage Titan 3TToshiba Medical Systems Corporation, Japan · 2011 · Recalled
- This deviceK113093 Vantage Titan 3TToshibamedical Systems Corporation · 2012
- Descendant · cites it directly · 52 of its ownK120487 Vantage Titan 3TToshibamedical Systems Corporation · 2012
- Descendant · 2 generations on · 37 of its ownK132160 Vantage Titan 3TToshibamedical Systems Corporation · 2013
- Descendant · 3 generations on · 36 of its ownK143008 Vantage Titan 3TToshibamedical Systems Corporation · 2015
- Descendant · 4 generations on · 32 of its ownK152371 Vantage Titan 3TToshibamedical Systems Corporation · 2015 · Recalled
- Descendant · 5 generations on · 31 of its ownK162183 Vantage Galan 3T, MRT-3020, V4.0Toshibamedical Systems Corporation · 2016
Showing 5 of 53 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 53 · See all- K120487Vantage Titan 3TToshibamedical Systems Corporation · 2012 · cites it directly52descendants
- K132160Vantage Titan 3TToshibamedical Systems Corporation · 2013 · 2 generations on37descendants
- K143008Vantage Titan 3TToshibamedical Systems Corporation · 2015 · 3 generations on36descendants
- K152371Vantage Titan 3TToshibamedical Systems Corporation · 2015 · 4 generations on32descendants
- K162183Vantage Galan 3T, MRT-3020, V4.0Toshibamedical Systems Corporation · 2016 · 5 generations on31descendants
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 | K102489 | Vantage Titan 3T | Toshiba Medical Systems Corporation, Japan | 2011 | 1 |
| 0 (this device) | K113093 | Vantage Titan 3T | Toshibamedical Systems Corporation | 2012 | — |
| +1 | K120487 | Vantage Titan 3T | Toshibamedical Systems Corporation | 2012 | — |
| +2 | K132160 | Vantage Titan 3T | Toshibamedical Systems Corporation | 2013 | — |
| +3 | K143008 | Vantage Titan 3T | Toshibamedical Systems Corporation | 2015 | — |
| +4 | K152371 | Vantage Titan 3T | Toshibamedical Systems Corporation | 2015 | 1 |
| +5 | K162183 | Vantage Galan 3T, MRT-3020, V4.0 | Toshibamedical Systems Corporation | 2016 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2015 | 4 | 0 |
| 2016 | 2 | 0 |
| 2017 | 3 | 0 |
| 2018 | 6 | 0 |
| 2019 | 3 | 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 |
|---|---|---|---|
| * | K102489 | Vantage Titan 3TSummary page 1…UBMISSION: October 17, 2011 6. DEVICE DESCRIPTION: The Vantage Titan 3T (Model MRT-3010/AS) is a 3 Tesla Magnetic Resonance Imaging (MRI) System (K102489). MRA (MR Angio) software package which functions are same as the MRA package of existing 1.5T MRI Vantage Titan (K080038) is… | 2011 |
| † | K080038 | Vantage Titan, Model MRT-1504/S3 | 2008 |
What descends from it? (53)
See all 531 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K120487 | Vantage Titan 3T | 2012 | 52 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| 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 4 companies; a new generation was cleared every 1.2 years on median.
- 7 of the 7 ancestors have a recall of any class.
- Of its descendants, K120487 (Toshibamedical Systems Corporation, 2012) has gone furthest, with 52 descendants of its own.
- 1 other device also cites its predicate K102489.
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?
Vantage Titan 3T systems are 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. Additionally, this system is capable of non-contrast enhanced imaging, such as MRA. MRI (magnetic resonance imaging) images correspond to the spatial distribution of protons (hydrogen nuclei) that exhibit nuclear resonance (NMR). The NMR…
Read the full statement (116 words)
Vantage Titan 3T systems are 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. Additionally, this system is capable of non-contrast enhanced imaging, such as MRA.
MRI (magnetic resonance imaging) images correspond to the spatial distribution of protons (hydrogen nuclei) that exhibit nuclear 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
*Ghemical shift
Contrast agent use us 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/K113093 · printed Nov 6, 2026
Cite this page
510(k) Report. “K113093: Vantage Titan 3T.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K113093
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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