510(k) · Cleared
Recalled · Class II · 2021Vantage Galan 3T, MRT-3020, V7.0 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 Feb 2, 2021 as substantially equivalent to K192574 (Canon Medical Systems Corporation, 2020) after a 60-day review. Its family tree reaches back 16 generations to 2000. 6 later devices descend from it. It has been recalled once.
- Decided
- Feb 2, 2021
- Review
- 60 days
- Class
- Class II
- Product code
- LNH
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 16 generations to K002531 (2000). 6 later devices descend from it, 1 citing it directly.
- Root · 16 generations backK002531 Excelart with Pianissimo, Model MRT-1501/P3Toshiba America Mri, Inc. · 2000 · Recalled
- 12 generations between
- 3 generations backK173382 Vantage Galan 3T, V4.6Toshibamedical Systems Corporation · 2018
- 2 generations backK181593 Vantage Galan 3T, MRT-3020/A7, V5.0Canon Medical Systems Corporation · 2018
- 1 generation backK192574 Vantage Galan 3T, MRT-3020, V6.0 with AiCE Reconstruction Processing…Canon Medical Systems Corporation · 2020
- This deviceK203553 Vantage Galan 3T, MRT-3020, V7.0 with AiCE Reconstruction Processing…Canon Medical Systems Corporation · 2021
- Descendant · cites it directly · 5 of its ownK212056 Vantage Galan 3T, MRT-3020, V7.0 with AiCE Reconstruction Processing…Canon Medical Systems Corporation · 2021
- Descendant · 2 generations on · 4 of its ownK220192 Vantage Galan 3T, MRT-3020, V8.0 with AiCE Reconstruction Processing…Canon Medical Systems Corporation · 2022
- Descendant · 3 generations on · 3 of its ownK222387 Vantage Galan 3T, MRT-3020, V8.0 with AiCE Reconstruction Processing…Canon Medical Systems Corporation · 2022
- Descendant · 4 generations on · 2 of its ownK230355 Vantage Galan 3T, MRT-3020, V9.0 with AiCE Reconstruction Processing…Canon Medical Systems Corporation · 2023 · Recalled
- Descendant · 5 generations on · 1 of its ownK241496 Vantage Galan 3T, MRT-3020, V10.0 with AiCE Reconstruction…Canon Medical Systems Corporation · 2024
Show all 16 generations
- Root · 16 generations backK002531 Excelart with Pianissimo, Model MRT-1501/P3Toshiba America Mri, Inc. · 2000 · Recalled
- 15 generations backK023511 Excelart with Pianissimo XG/AG Spin Edition, Model MRT-1501/P3, P2Toshiba America Medical Systems, In.C · 2002 · Recalled
- 14 generations backK032490 Toshiba Excelart Vantage XGV/Agv Mri Diagnostic System, Models…Toshiba America Medical Systems, In.C · 2003 · Recalled
- 13 generations backK060003 Excelart Vantage ZGVToshibamedical Systems Corporation · 2006 · Recalled
- 12 generations backK063361 Excelart Vantage Atlas, Model MRT-1503Toshiba America Medical Systems, In.C · 2006 · Recalled
- 11 generations backK080038 Vantage Titan, Model MRT-1504/S3Toshiba America Medical Systems, In.C · 2008 · Recalled
- 10 generations backK102489 Vantage Titan 3TToshiba Medical Systems Corporation, Japan · 2011 · Recalled
- 9 generations backK113093 Vantage Titan 3TToshibamedical Systems Corporation · 2012 · Recalled
- 8 generations backK120487 Vantage Titan 3TToshibamedical Systems Corporation · 2012
- 7 generations backK132160 Vantage Titan 3TToshibamedical Systems Corporation · 2013
- 6 generations backK143008 Vantage Titan 3TToshibamedical Systems Corporation · 2015
- 5 generations backK152371 Vantage Titan 3TToshibamedical Systems Corporation · 2015 · Recalled
- 4 generations backK162183 Vantage Galan 3T, MRT-3020, V4.0Toshibamedical Systems Corporation · 2016
- 3 generations backK173382 Vantage Galan 3T, V4.6Toshibamedical Systems Corporation · 2018
- 2 generations backK181593 Vantage Galan 3T, MRT-3020/A7, V5.0Canon Medical Systems Corporation · 2018
- 1 generation backK192574 Vantage Galan 3T, MRT-3020, V6.0 with AiCE Reconstruction Processing…Canon Medical Systems Corporation · 2020
- This deviceK203553 Vantage Galan 3T, MRT-3020, V7.0 with AiCE Reconstruction Processing…Canon Medical Systems Corporation · 2021
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K212056Vantage Galan 3T, MRT-3020, V7.0 with AiCE Reconstruction Processing Unit for MRCanon Medical Systems Corporation · 2021 · cites it directly5descendants
- K220192Vantage Galan 3T, MRT-3020, V8.0 with AiCE Reconstruction Processing Unit for MRCanon Medical Systems Corporation · 2022 · 2 generations on4descendants
- K222387Vantage Galan 3T, MRT-3020, V8.0 with AiCE Reconstruction Processing Unit for MRCanon Medical Systems Corporation · 2022 · 3 generations on3descendants
- K230355Vantage Galan 3T, MRT-3020, V9.0 with AiCE Reconstruction Processing Unit for MRCanon Medical Systems Corporation · 2023 · 4 generations on2descendants
- K241496Vantage Galan 3T, MRT-3020, V10.0 with AiCE Reconstruction Processing Unit for MRCanon Medical Systems Corporation · 2024 · 5 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −16 | K002531 | Excelart with Pianissimo, Model MRT-1501/P3 | Toshiba America Mri, Inc. | 2000 | 4 |
| −15 | K023511 | Excelart with Pianissimo XG/AG Spin Edition, Model MRT-1501/P3, P2 | Toshiba America Medical Systems, In.C | 2002 | 2 |
| −14 | K032490 | Toshiba Excelart Vantage XGV/Agv Mri Diagnostic System, Models MRT-1503/P3 and… | Toshiba America Medical Systems, In.C | 2003 | 3 |
| −13 | K060003 | Excelart Vantage ZGV | Toshibamedical Systems Corporation | 2006 | 1 |
| −12 | K063361 | Excelart Vantage Atlas, Model MRT-1503 | Toshiba America Medical Systems, In.C | 2006 | 1 |
| −11 | K080038 | Vantage Titan, Model MRT-1504/S3 | Toshiba America Medical Systems, In.C | 2008 | 2 |
| −10 | K102489 | Vantage Titan 3T | Toshiba Medical Systems Corporation, Japan | 2011 | 1 |
| −9 | K113093 | Vantage Titan 3T | Toshibamedical Systems Corporation | 2012 | 1 |
| −8 | K120487 | Vantage Titan 3T | Toshibamedical Systems Corporation | 2012 | — |
| −7 | K132160 | Vantage Titan 3T | Toshibamedical Systems Corporation | 2013 | — |
| −6 | K143008 | Vantage Titan 3T | Toshibamedical Systems Corporation | 2015 | — |
| −5 | K152371 | Vantage Titan 3T | Toshibamedical Systems Corporation | 2015 | 1 |
| −4 | K162183 | Vantage Galan 3T, MRT-3020, V4.0 | Toshibamedical Systems Corporation | 2016 | — |
| −3 | K173382 | Vantage Galan 3T, V4.6 | Toshibamedical Systems Corporation | 2018 | — |
| −2 | K181593 | Vantage Galan 3T, MRT-3020/A7, V5.0 | Canon Medical Systems Corporation | 2018 | — |
| −1 | K192574 | Vantage Galan 3T, MRT-3020, V6.0 with AiCE Reconstruction Processing Unit for MR | Canon Medical Systems Corporation | 2020 | — |
| 0 (this device) | K203553 | Vantage Galan 3T, MRT-3020, V7.0 with AiCE Reconstruction Processing Unit for MR | Canon Medical Systems Corporation | 2021 | — |
| +1 | K212056 | Vantage Galan 3T, MRT-3020, V7.0 with AiCE Reconstruction Processing Unit for MR | Canon Medical Systems Corporation | 2021 | — |
| +2 | 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 | — |
| +4 | K230355 | Vantage Galan 3T, MRT-3020, V9.0 with AiCE Reconstruction Processing Unit for MR | Canon Medical Systems Corporation | 2023 | 2 |
| +5 | K241496 | Vantage Galan 3T, MRT-3020, V10.0 with AiCE Reconstruction Processing Unit for… | Canon Medical Systems Corporation | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 1 | 0 |
| 2022 | 2 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 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 |
|---|---|---|---|
| * | K192574 | Vantage Galan 3T, MRT-3020, V6.0 with AiCE Reconstruction Processing Unit for MRSummary page 5…90-LNH 14. PREDICATE DEVICE Predicate Device: Vantage Galan 3T, MRT-3020, V6.0 with AiCE Reconstruction Processing Unit for MR (K192574) Subject Device Predicate Device… | 2020 |
What descends from it? (6)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K212056 | Vantage Galan 3T, MRT-3020, V7.0 with AiCE Reconstruction Processing Unit for MR | 2021 | 5 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 21, 2021 | Class II | Z-2047-2021 | 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 21 years and passes through 5 companies; a new generation was cleared every 1.2 years on median.
- 9 of the 16 ancestors have a recall of any class.
- Of its descendants, K212056 (Canon Medical Systems Corporation, 2021) has gone furthest, with 5 descendants of its own.
- 1 other device also cites its predicate K192574.
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. 2021, 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 (T1)
•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/K203553 · printed Nov 4, 2026
Cite this page
510(k) Report. “K203553: Vantage Galan 3T, MRT-3020, V7.0 with AiCE Reconstruction Processing Unit for MR.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K203553
Report an extraction error
Are you the manufacturer?
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