510(k) · Cleared
Recalled · Class II · 2025Vantage Galan 3T, MRT-3020, V10.0 with AiCE Reconstruction Processing Unit for MR
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Canon Medical Systems Corporation · LNH System, Nuclear Magnetic Resonance Imaging
Cleared on Jan 7, 2025 as substantially equivalent to K241496 (Canon Medical Systems Corporation, 2024) after a 75-day review. Its family tree reaches back 22 generations to 2000. It has been recalled once.
- Decided
- Jan 7, 2025
- Review
- 75 days
- Class
- Class II
- Product code
- LNH
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 22 generations to K002531 (2000). No later device cites it as a predicate yet.
- Root · 22 generations backK002531 Excelart with Pianissimo, Model MRT-1501/P3Toshiba America Mri, Inc. · 2000 · Recalled
- 18 generations between
- 3 generations backK222387 Vantage Galan 3T, MRT-3020, V8.0 with AiCE Reconstruction Processing…Canon Medical Systems Corporation · 2022
- 2 generations backK230355 Vantage Galan 3T, MRT-3020, V9.0 with AiCE Reconstruction Processing…Canon Medical Systems Corporation · 2023 · Recalled
- 1 generation backK241496 Vantage Galan 3T, MRT-3020, V10.0 with AiCE Reconstruction…Canon Medical Systems Corporation · 2024
- This deviceK243335 Vantage Galan 3T, MRT-3020, V10.0 with AiCE Reconstruction…Canon Medical Systems Corporation · 2025
Show all 22 generations
- Root · 22 generations backK002531 Excelart with Pianissimo, Model MRT-1501/P3Toshiba America Mri, Inc. · 2000 · Recalled
- 21 generations backK023511 Excelart with Pianissimo XG/AG Spin Edition, Model MRT-1501/P3, P2Toshiba America Medical Systems, In.C · 2002 · Recalled
- 20 generations backK032490 Toshiba Excelart Vantage XGV/Agv Mri Diagnostic System, Models…Toshiba America Medical Systems, In.C · 2003 · Recalled
- 19 generations backK060003 Excelart Vantage ZGVToshibamedical Systems Corporation · 2006 · Recalled
- 18 generations backK063361 Excelart Vantage Atlas, Model MRT-1503Toshiba America Medical Systems, In.C · 2006 · Recalled
- 17 generations backK080038 Vantage Titan, Model MRT-1504/S3Toshiba America Medical Systems, In.C · 2008 · Recalled
- 16 generations backK102489 Vantage Titan 3TToshiba Medical Systems Corporation, Japan · 2011 · Recalled
- 15 generations backK113093 Vantage Titan 3TToshibamedical Systems Corporation · 2012 · Recalled
- 14 generations backK120487 Vantage Titan 3TToshibamedical Systems Corporation · 2012
- 13 generations backK132160 Vantage Titan 3TToshibamedical Systems Corporation · 2013
- 12 generations backK143008 Vantage Titan 3TToshibamedical Systems Corporation · 2015
- 11 generations backK152371 Vantage Titan 3TToshibamedical Systems Corporation · 2015 · Recalled
- 10 generations backK162183 Vantage Galan 3T, MRT-3020, V4.0Toshibamedical Systems Corporation · 2016
- 9 generations backK173382 Vantage Galan 3T, V4.6Toshibamedical Systems Corporation · 2018
- 8 generations backK181593 Vantage Galan 3T, MRT-3020/A7, V5.0Canon Medical Systems Corporation · 2018
- 7 generations backK192574 Vantage Galan 3T, MRT-3020, V6.0 with AiCE Reconstruction Processing…Canon Medical Systems Corporation · 2020
- 6 generations backK203553 Vantage Galan 3T, MRT-3020, V7.0 with AiCE Reconstruction Processing…Canon Medical Systems Corporation · 2021 · Recalled
- 5 generations backK212056 Vantage Galan 3T, MRT-3020, V7.0 with AiCE Reconstruction Processing…Canon Medical Systems Corporation · 2021
- 4 generations backK220192 Vantage Galan 3T, MRT-3020, V8.0 with AiCE Reconstruction Processing…Canon Medical Systems Corporation · 2022
- 3 generations backK222387 Vantage Galan 3T, MRT-3020, V8.0 with AiCE Reconstruction Processing…Canon Medical Systems Corporation · 2022
- 2 generations backK230355 Vantage Galan 3T, MRT-3020, V9.0 with AiCE Reconstruction Processing…Canon Medical Systems Corporation · 2023 · Recalled
- 1 generation backK241496 Vantage Galan 3T, MRT-3020, V10.0 with AiCE Reconstruction…Canon Medical Systems Corporation · 2024
- This deviceK243335 Vantage Galan 3T, MRT-3020, V10.0 with AiCE Reconstruction…Canon Medical Systems Corporation · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −22 | K002531 | Excelart with Pianissimo, Model MRT-1501/P3 | Toshiba America Mri, Inc. | 2000 | 4 |
| −21 | K023511 | Excelart with Pianissimo XG/AG Spin Edition, Model MRT-1501/P3, P2 | Toshiba America Medical Systems, In.C | 2002 | 2 |
| −20 | K032490 | Toshiba Excelart Vantage XGV/Agv Mri Diagnostic System, Models MRT-1503/P3 and… | Toshiba America Medical Systems, In.C | 2003 | 3 |
| −19 | K060003 | Excelart Vantage ZGV | Toshibamedical Systems Corporation | 2006 | 1 |
| −18 | K063361 | Excelart Vantage Atlas, Model MRT-1503 | Toshiba America Medical Systems, In.C | 2006 | 1 |
| −17 | K080038 | Vantage Titan, Model MRT-1504/S3 | Toshiba America Medical Systems, In.C | 2008 | 2 |
| −16 | K102489 | Vantage Titan 3T | Toshiba Medical Systems Corporation, Japan | 2011 | 1 |
| −15 | K113093 | Vantage Titan 3T | Toshibamedical Systems Corporation | 2012 | 1 |
| −14 | K120487 | Vantage Titan 3T | Toshibamedical Systems Corporation | 2012 | — |
| −13 | K132160 | Vantage Titan 3T | Toshibamedical Systems Corporation | 2013 | — |
| −12 | K143008 | Vantage Titan 3T | Toshibamedical Systems Corporation | 2015 | — |
| −11 | K152371 | Vantage Titan 3T | Toshibamedical Systems Corporation | 2015 | 1 |
| −10 | K162183 | Vantage Galan 3T, MRT-3020, V4.0 | Toshibamedical Systems Corporation | 2016 | — |
| −9 | K173382 | Vantage Galan 3T, V4.6 | Toshibamedical Systems Corporation | 2018 | — |
| −8 | K181593 | Vantage Galan 3T, MRT-3020/A7, V5.0 | Canon Medical Systems Corporation | 2018 | — |
| −7 | K192574 | Vantage Galan 3T, MRT-3020, V6.0 with AiCE Reconstruction Processing Unit for MR | Canon Medical Systems Corporation | 2020 | — |
| −6 | K203553 | Vantage Galan 3T, MRT-3020, V7.0 with AiCE Reconstruction Processing Unit for MR | Canon Medical Systems Corporation | 2021 | 1 |
| −5 | K212056 | Vantage Galan 3T, MRT-3020, V7.0 with AiCE Reconstruction Processing Unit for MR | Canon Medical Systems Corporation | 2021 | — |
| −4 | K220192 | Vantage Galan 3T, MRT-3020, V8.0 with AiCE Reconstruction Processing Unit for MR | Canon Medical Systems Corporation | 2022 | — |
| −3 | K222387 | Vantage Galan 3T, MRT-3020, V8.0 with AiCE Reconstruction Processing Unit for MR | Canon Medical Systems Corporation | 2022 | — |
| −2 | K230355 | Vantage Galan 3T, MRT-3020, V9.0 with AiCE Reconstruction Processing Unit for MR | Canon Medical Systems Corporation | 2023 | 2 |
| −1 | K241496 | Vantage Galan 3T, MRT-3020, V10.0 with AiCE Reconstruction Processing Unit for… | Canon Medical Systems Corporation | 2024 | — |
| 0 (this device) | K243335 | Vantage Galan 3T, MRT-3020, V10.0 with AiCE Reconstruction Processing Unit for… | Canon Medical Systems Corporation | 2025 | — |
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 |
|---|---|---|---|
| * | K241496 | Vantage Galan 3T, MRT-3020, V10.0 with AiCE Reconstruction Processing Unit for MRSummary page 6…90-LNH 14. PREDICATE DEVICE Predicate Device: Vantage Galan 3T, MRT-3020, V10.0 with AiCE Reconstruction Processing Unit for MR (K241496) Predicate Device System Vantage Galan 3T,… | 2024 |
| † | K230355 | Vantage Galan 3T, MRT-3020, V9.0 with AiCE Reconstruction Processing Unit for MR | 2023 |
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 |
|---|---|---|---|---|
| Oct 16, 2025 | Class II | Z-0327-2026 | Device Design | Affected system contains components that do not meet the required distance between electrodes for compliance with the IEC 60601-1 standard for medical electrical equipment. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 25 years and passes through 5 companies; a new generation was cleared every 12 months on median.
- 11 of the 22 ancestors have a recall of any class.
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. 2025, 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 Galan 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 magnetic resonance (NMR). The…
Read the full statement (118 words)
Vantage Galan 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 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
Depending on the region of interest, contrast agents may be used. 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/K243335 · printed Nov 5, 2026
Cite this page
510(k) Report. “K243335: Vantage Galan 3T, MRT-3020, V10.0 with AiCE Reconstruction Processing Unit for MR.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K243335
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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