510(k) · Cleared
ClearedVantage Orian 1.5T, MRT-1550, V6.0 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 Jul 14, 2020 as substantially equivalent to K193021 (Canon Medical Systems Corporation, 2020) after a 250-day review. Its family tree reaches back 16 generations to 2000. 3 later devices descend from it.
- Decided
- Jul 14, 2020
- Review
- 250 days
- Class
- Class II
- Product code
- LNH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 16 generations to K002531 (2000). 21 ancestors in all. 3 later devices descend from it, 2 citing it directly.
- Root · 16 generations backK002531 Excelart with Pianissimo, Model MRT-1501/P3Toshiba America Mri, Inc. · 2000 · Recalled
- 12 generations between
- 3 generations backK170412 Vantage Titan 1.5T, MRT-1510, M-Power GXToshibamedical Systems Corporation · 2017 · Recalled
- 2 generations backK182282 Vantage Orian 1.5T, MRT-1550, V4.5Canon Medical Systems Corporation · 2018
- 1 generation backK193021 Vantage Orian 1.5T, MRT-1550, V6.0Canon Medical Systems Corporation · 2020
- This deviceK193097 Vantage Orian 1.5T, MRT-1550, V6.0 with AiCE Reconstruction…Canon Medical Systems Corporation · 2020
- Descendant · cites it directly · 1 of its ownK202767 Vantage Orian 1.5T, MRT-1550, V6.0Canon Medical Systems Corporation · 2021
- Descendant · 2 generations on · 0 of its ownK210340 Vantage Orian 1.5T, MRT-1550, V6.0 with AiCE Reconstruction…Canon Medical Systems Corporation · 2021
- Descendant · cites it directly · 0 of its ownK203053 Vantage Orian 1.5T, MRT-1550, V7.0 with AiCE Reconstruction…Canon Medical Systems Corporation · 2020
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 backK150427 Vantage Titan 1.5T, V3.1, MRT-1510Toshibamedical Systems Corporation · 2015
- 4 generations backK160632 Vantage Titan 1.5T, MRT-1510, V3.6 SoftwareToshibamedical Systems Corporation · 2016
- 3 generations backK170412 Vantage Titan 1.5T, MRT-1510, M-Power GXToshibamedical Systems Corporation · 2017 · Recalled
- 2 generations backK182282 Vantage Orian 1.5T, MRT-1550, V4.5Canon Medical Systems Corporation · 2018
- 1 generation backK193021 Vantage Orian 1.5T, MRT-1550, V6.0Canon Medical Systems Corporation · 2020
- This deviceK193097 Vantage Orian 1.5T, MRT-1550, V6.0 with AiCE Reconstruction…Canon Medical Systems Corporation · 2020
Most influential descendants
Showing 3 of 3 · See all- K202767Vantage Orian 1.5T, MRT-1550, V6.0Canon Medical Systems Corporation · 2021 · cites it directly1descendant
- K210340Vantage Orian 1.5T, MRT-1550, V6.0 with AiCE Reconstruction Processing Unit for MRCanon Medical Systems Corporation · 2021 · 2 generations on0descendants
- K203053Vantage Orian 1.5T, MRT-1550, V7.0 with AiCE Reconstruction Processing Unit for MRCanon Medical Systems Corporation · 2020 · cites it directly0descendants
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 | K150427 | Vantage Titan 1.5T, V3.1, MRT-1510 | Toshibamedical Systems Corporation | 2015 | — |
| −4 | 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 |
| −2 | K182282 | Vantage Orian 1.5T, MRT-1550, V4.5 | Canon Medical Systems Corporation | 2018 | — |
| −1 | K193021 | Vantage Orian 1.5T, MRT-1550, V6.0 | Canon Medical Systems Corporation | 2020 | — |
| 0 (this device) | K193097 | Vantage Orian 1.5T, MRT-1550, V6.0 with AiCE Reconstruction Processing Unit… | Canon Medical Systems Corporation | 2020 | — |
| +1 | K202767 | Vantage Orian 1.5T, MRT-1550, V6.0 | Canon Medical Systems Corporation | 2021 | — |
| +2 | K210340 | Vantage Orian 1.5T, MRT-1550, V6.0 with AiCE Reconstruction Processing Unit… | Canon Medical Systems Corporation | 2021 | — |
| +1 | K203053 | Vantage Orian 1.5T, MRT-1550, V7.0 with AiCE Reconstruction Processing Unit… | Canon Medical Systems Corporation | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 1 | 0 |
| 2021 | 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 |
|---|---|---|---|
| * | K193021 | Vantage Orian 1.5T, MRT-1550, V6.0 Cleared while this submission was under review Summary page 5…onance Diagnostic Device) 13. PRODUCT CODE 90-LNH 14. PREDICATE DEVICE Predicate Device: Vantage Orian 1.5T, MRT-1550, V6.0 (K193021) Reference Device: Vantage Galan 3T, MRT-3020, V6.0 with AiCE Reconstruction Processing Unit for MR (K192… | 2020 |
| † | K192574 | Vantage Galan 3T, MRT-3020, V6.0 with AiCE Reconstruction Processing Unit for MR | 2020 |
What descends from it? (3)
2 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)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 20 years and passes through 5 companies; a new generation was cleared every 1.4 years on median.
- 11 of the 21 ancestors have a recall of any class.
- Of its descendants, K202767 (Canon Medical Systems Corporation, 2021) has gone furthest, with 1 descendant of its own.
- 2 other devices also cite its predicate K193021.
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. 2020, 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 Orian 1.5T 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 Orian 1.5T 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/K193097 · printed Nov 4, 2026
Cite this page
510(k) Report. “K193097: Vantage Orian 1.5T, MRT-1550, V6.0 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/K193097
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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