510(k) · Cleared
Recalled · Class II · 2024Vantage Titan with Helios Gradient Model MRT-1504/US
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 Dec 13, 2012 as substantially equivalent to K120638 (Toshibamedical Systems Corporation, 2012) and 1 other predicate after a 108-day review. Its family tree reaches back 8 generations to 2000. It has been recalled 3 times.
- Decided
- Dec 13, 2012
- Review
- 108 days
- Class
- Class II
- Product code
- LNH
- Recalls
- 3
- Predicates
- 2
Its longest line of descent runs back 8 generations to K002531 (2000). No later device cites it as a predicate yet.
- Root · 8 generations backK002531 Excelart with Pianissimo, Model MRT-1501/P3Toshiba America Mri, Inc. · 2000 · Recalled
- 7 generations backK023511 Excelart with Pianissimo XG/AG Spin Edition, Model MRT-1501/P3, P2Toshiba America Medical Systems, In.C · 2002 · Recalled
- 6 generations backK032490 Toshiba Excelart Vantage XGV/Agv Mri Diagnostic System, Models…Toshiba America Medical Systems, In.C · 2003 · Recalled
- 5 generations backK060003 Excelart Vantage ZGVToshibamedical Systems Corporation · 2006 · Recalled
- 4 generations backK063361 Excelart Vantage Atlas, Model MRT-1503Toshiba America Medical Systems, In.C · 2006 · Recalled
- 3 generations backK080038 Vantage Titan, Model MRT-1504/S3Toshiba America Medical Systems, In.C · 2008 · Recalled
- 2 generations backK112003 Vantage Titan HSRToshibamedical Systems Corporation · 2011
- 1 generation backK120638 Vantage TitanToshibamedical Systems Corporation · 2012 · Recalled
- This deviceK122613 Vantage Titan with Helios Gradient Model MRT-1504/USToshiba America Medical Systems, In.C · 2012
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K002531 | Excelart with Pianissimo, Model MRT-1501/P3 | Toshiba America Mri, Inc. | 2000 | 4 |
| −7 | K023511 | Excelart with Pianissimo XG/AG Spin Edition, Model MRT-1501/P3, P2 | Toshiba America Medical Systems, In.C | 2002 | 2 |
| −6 | K032490 | Toshiba Excelart Vantage XGV/Agv Mri Diagnostic System, Models MRT-1503/P3 and… | Toshiba America Medical Systems, In.C | 2003 | 3 |
| −5 | K060003 | Excelart Vantage ZGV | Toshibamedical Systems Corporation | 2006 | 1 |
| −4 | K063361 | Excelart Vantage Atlas, Model MRT-1503 | Toshiba America Medical Systems, In.C | 2006 | 1 |
| −3 | K080038 | Vantage Titan, Model MRT-1504/S3 | Toshiba America Medical Systems, In.C | 2008 | 2 |
| −2 | K112003 | Vantage Titan HSR | Toshibamedical Systems Corporation | 2011 | — |
| −1 | K120638 | Vantage Titan | Toshibamedical Systems Corporation | 2012 | 2 |
| 0 (this device) | K122613 | Vantage Titan with Helios Gradient Model MRT-1504/US | Toshiba America Medical Systems, In.C | 2012 | — |
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 |
|---|---|---|---|
| * | K120638 | Vantage TitanSummary page 2…otification 51 0(k) Vantage Titan, v2.1, MRT-I 504/US 8. PREDICATE DEVICE(S): a. K120638: Vantage Titan, MRT-1504/U4 b. K1 12003: Vantage Titan HSR,I MRT-1 504/AS 9. REASON FOR SUMBISSION: Modificat… | 2012 |
| * | K112003 | Vantage Titan HSRSummary page 2…Vantage Titan, v2.1, MRT-I 504/US 8. PREDICATE DEVICE(S): a. K120638: Vantage Titan, MRT-1504/U4 b. K1 12003: Vantage Titan HSR,I MRT-1 504/AS 9. REASON FOR SUMBISSION: Modification of adceared device 10. Submission Type Tra… | 2011 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 10, 2024 | Class II | Z-2041-2024 | Device Design | The terminal block used to secure the power supply cable for the gradient coil of the MRI system was not secured as designed, which could cause cable disconnection, which could lead to arcing, followed by melting of the cable, ignition… |
| Jan 29, 2024 | Class II | Z-1250-2024 | Component change control | For some MRI systems, it has been found that some of the maximum Spatial Field Gradient (SFG) values displayed in "System Information" of the operation window and some of the maximum SFG values described in the safety manual are lower… |
| May 21, 2021 | Class II | Z-2044-2021 | Under Investigation by firm | The MRI system contains a component that does not meet the appropriate flame retardancy-rating which could result in smoke or fire. |
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.
- 7 of the 8 ancestors have a recall of any class.
- 2 other devices also cite its predicate K120638.
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 (Ti1),
- Spin-spih 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/K122613 · printed Nov 6, 2026
Cite this page
510(k) Report. “K122613: Vantage Titan with Helios Gradient Model MRT-1504/US.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K122613
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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