Vantage Galan 3T, MRT-3020, V8.0 with AiCE Reconstruction Processing Unit for MR

K220192

Canon Medical Systems Corporation · cleared 2022-04-08 · product code LNH · Radiology

Premarket evidence — what FDA accepted

Device typehardware with ml
source quote (p.1)
“Vantage Galan 3T, MRT-3020, V8.0 with AiCE Reconstruction Processing Unit for MR. LiverLine+: Machine Learning based detection technology for liver plane. ProstateLine+: Machine Learning based detection technology for prostate plane. W-SpineLine+: Machine Learning based detection technology for spine plane.”
AlgorithmmART EXP is a 3D method to reduce in-plane and through plane distortion artifact induced by susceptibility. RDC DWI is a method to reduce distortion in phase encoding direction. pCASL is an arterial spin labeling technique. IMC (Iterative Motion Correction) reduces motion artifact. SureVOI Liver automatically detects liver area and plan scan position. LiverLine+, ProstateLine+, and W-SpineLine+ use Machine Learning based detection technology for liver, prostate, and spine planes respectively.
source quote (p.6)
“mART EXP: mART EXP is 3D method to reduce in-plane and through plane distortion artifact induced by susceptibility. Each slice is 3D phase encoded to reduce distortion artifact induced by susceptibility in slice dimension. In addition, this application combines with VAT (View Angle Tilting) method for reducing in-plane distortion artifact induced by susceptibility. In the reconstruction, the data of each slice which is encoded in the slice dimension is combined and corrected, and finally the images are registered as 2D multislice images like normal FSE2D. In addition, this application can be used in combination with Compressed SPEEDER application to reduce scan time. RDC DWI is the method to reduce distortion in phase encoding direction for SEEPI2D sequence. pCASL (pseudo-continuous ASL): pCASL is one of the arterial spin labeling (ASL) techniques which can provide perfusion-weighted images without contrast media by subtracting the tag image from the control image. Iterative Motion Correction (IMC): IMC reduces motion artifact by correcting k-space data based on detecting the amount of motion during scan. SureVOI Liver: SureVOI Liver automatically detects liver area and plan scan position for skimming scan, map scan, axial scan, coronal scan, probe scan for Real-time Motion Correction (RMC), and FatSatPrep scan. LiverLine+: Machine Learning based detection technology for liver plane. ProstateLine+: Machine Learning based detection technology for prostate plane. W-SpineLine+: Machine Learning based detection technology for spine plane.”
Adaptive (vs locked)No
PCCPNo
Cybersecurity addressedNo

Validation studies (2)

Retrospective clinical

sample size not stated

endpoints: features worked as intended; images were of diagnostic quality; test results met predetermined acceptance criteria; effective in reducing motion artifacts; CBF values met predetermined acceptance criteria; percentage of successful patient orientation detection and cases requiring no correction met predetermined acceptance criteria

standards: ANSI AAMI ES60601-1:2005 / (R)2012 and A1:2012, IEC60601-1-2 (2014), IEC60601-1-6 (2010), Amd.1 (2013), IEC60601-2-33 (2010), Amd.1 (2013), Amd.2 (2015), IEC60825-1 (2007, 2014), IEC62304 (2006), Amd.1 (2015), IEC62366-1 (2020), NEMA MS 1 (2008), NEMA MS 2 (2008), NEMA MS 3 (2008), NEMA MS 4 (2010), NEMA MS 5 (2010)

Bench

sample size not stated

endpoints: reduces artifacts caused by unfolding errors; scanning can be conducted without problems; reduce distortion artifacts

standards: ANSI AAMI ES60601-1:2005 / (R)2012 and A1:2012, IEC60601-1-2 (2014), IEC60601-1-6 (2010), Amd.1 (2013), IEC60601-2-33 (2010), Amd.1 (2013), Amd.2 (2015), IEC60825-1 (2007, 2014), IEC62304 (2006), Amd.1 (2015), IEC62366-1 (2020), NEMA MS 1 (2008), NEMA MS 2 (2008), NEMA MS 3 (2008), NEMA MS 4 (2010), NEMA MS 5 (2010)

Reported performance (0 observations)

FDA source did not state a quantitative performance metric — non-reporting is itself the signal.

Each value carries its own analysis unit and task — never compare or pool across devices. Source: 510(k) summary PDF.

Predicate network

Postmarket — what happened after clearance

100
recalls in product code, 24mo
510
MAUDE reports in code, 12mo
+5%
vs code's own 3-yr baseline
5
drift signals on this device
  • re_clearance

    The FDA AI/ML device list shows a newer 510(k) K243335 (decision 2025-01-07) from Canon Medical Systems Corporation for a matching device line ("Vantage Galan 3T, MRT-3020, V10.0 with AiCE Reconstruction Processing Unit for MR") — a new clearance for the same line is a change event.

    first seen 2026-07-08 · k_number:K243335

  • re_clearance

    The FDA AI/ML device list shows a newer 510(k) K241496 (decision 2024-08-20) from Canon Medical Systems Corporation for a matching device line ("Vantage Galan 3T, MRT-3020, V10.0 with AiCE Reconstruction Processing Unit for MR") — a new clearance for the same line is a change event.

    first seen 2026-07-08 · k_number:K241496

  • re_clearance

    The FDA AI/ML device list shows a newer 510(k) K230355 (decision 2023-08-30) from Canon Medical Systems Corporation for a matching device line ("Vantage Galan 3T, MRT-3020, V9.0 with AiCE Reconstruction Processing Unit for MR") — a new clearance for the same line is a change event.

    first seen 2026-07-08 · k_number:K230355

  • recall_reason_pattern

    Software/algorithm-related recall in product code LNH (Philips North America, initiated 2026-04-14): "The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading to the reconstruction " Recalling firm is another firm in the same product code.

    first seen 2026-07-08 · recall res_event_number:98779

  • recall_reason_pattern

    Software/algorithm-related recall in product code LNH (Philips North America, initiated 2025-12-03): "The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness maps to viewer Picture Archiving and Communication System (PACS)." Recalling firm is another firm in the same product code.

    first seen 2026-07-08 · recall res_event_number:98111

Recalls attributed to this device

  • Recalling firm matches this device's applicant (GE Medical Systems, LLC) — same firm and product code, not necessarily this device · initiated 2025-06-20

    GE HealthCare has become aware that for certain MR systems (SIGNA Artist, SIGNA Voyager, Discovery MR450 1.5T, Optima MR450w 1.5T, SIGNA Architect, SIGNA Premier, SIGNA UHP, Discovery MR750 3.0T, Discovery MR750w 3.0T, SIGNA Hero, SIGNA PET/MR, SIGNA Artist Evo, SIGNA Voyager AIR (China Only), SIGNA Architect AIR (China Only), SIGNA Premier XT (China Only), SIGNA Premier Elite (China Only), SIGNA Premier MAX (China Only), SIGNA Hero XT (China Only), SIGNA Hero Elite (China Only), SIGNA Hero MAX (China Only), SIGNA PET/MR AIR (China Only), SIGNA PET/MR AIR Plus (China Only), the planned maintenance steps to check the functionality of the caster locks on the MR patient table may not have been performed.

    recall event 97187 (openFDA)

  • Recalling firm matches this device's applicant (GE Medical Systems, LLC) — same firm and product code, not necessarily this device · initiated 2025-06-20

    GE HealthCare has become aware that for certain MR systems (SIGNA Artist, SIGNA Voyager, Discovery MR450 1.5T, Optima MR450w 1.5T, SIGNA Architect, SIGNA Premier, SIGNA UHP, Discovery MR750 3.0T, Discovery MR750w 3.0T, SIGNA Hero, SIGNA PET/MR, SIGNA Artist Evo, SIGNA Voyager AIR (China Only), SIGNA Architect AIR (China Only), SIGNA Premier XT (China Only), SIGNA Premier Elite (China Only), SIGNA Premier MAX (China Only), SIGNA Hero XT (China Only), SIGNA Hero Elite (China Only), SIGNA Hero MAX (China Only), SIGNA PET/MR AIR (China Only), SIGNA PET/MR AIR Plus (China Only), the planned maintenance steps to check the functionality of the caster locks on the MR patient table may not have been performed.

    recall event 97187 (openFDA)

  • Recalling firm matches this device's applicant (GE Medical Systems, LLC) — same firm and product code, not necessarily this device · initiated 2025-06-20

    GE HealthCare has become aware that for certain MR systems (SIGNA Artist, SIGNA Voyager, Discovery MR450 1.5T, Optima MR450w 1.5T, SIGNA Architect, SIGNA Premier, SIGNA UHP, Discovery MR750 3.0T, Discovery MR750w 3.0T, SIGNA Hero, SIGNA PET/MR, SIGNA Artist Evo, SIGNA Voyager AIR (China Only), SIGNA Architect AIR (China Only), SIGNA Premier XT (China Only), SIGNA Premier Elite (China Only), SIGNA Premier MAX (China Only), SIGNA Hero XT (China Only), SIGNA Hero Elite (China Only), SIGNA Hero MAX (China Only), SIGNA PET/MR AIR (China Only), SIGNA PET/MR AIR Plus (China Only), the planned maintenance steps to check the functionality of the caster locks on the MR patient table may not have been performed.

    recall event 97187 (openFDA)

  • Recalling firm matches this device's applicant (GE Medical Systems, LLC) — same firm and product code, not necessarily this device · initiated 2025-06-20

    GE HealthCare has become aware that for certain MR systems (SIGNA Artist, SIGNA Voyager, Discovery MR450 1.5T, Optima MR450w 1.5T, SIGNA Architect, SIGNA Premier, SIGNA UHP, Discovery MR750 3.0T, Discovery MR750w 3.0T, SIGNA Hero, SIGNA PET/MR, SIGNA Artist Evo, SIGNA Voyager AIR (China Only), SIGNA Architect AIR (China Only), SIGNA Premier XT (China Only), SIGNA Premier Elite (China Only), SIGNA Premier MAX (China Only), SIGNA Hero XT (China Only), SIGNA Hero Elite (China Only), SIGNA Hero MAX (China Only), SIGNA PET/MR AIR (China Only), SIGNA PET/MR AIR Plus (China Only), the planned maintenance steps to check the functionality of the caster locks on the MR patient table may not have been performed.

    recall event 97187 (openFDA)

Recall and MAUDE counts are product-code-level (reports aren't reliably attributable to one device); a recall is shown as device-attributed only when the recall record itself lists this clearance number. Signals are descriptive observables with sources — never a judgment that the device is unsafe or drifting. Snapshot 2026-07-08.

Reimbursement — how devices like this got paid

Not yet tracked — no payment pathway indexed for this clearance (the reimbursement corpus is a growing seed set).

Applicable FDA guidance — what the submission is measured against

FDA guidance documents and guiding principles applicable to 510(k) AI/ML devices in the Radiology panel. A curated reference index, not legal or regulatory advice — each item states its own status, and a draft is never binding.

Applicability is derived from the device's FDA advisory panel and pathway — cross-cutting guidances apply to every AI/ML device; panel-specific ones are flagged. Titles, dates, and links verified against fda.gov as of July 2026.

Constat Precedent · public FDA/CMS data · descriptive decision-support, not regulatory or reimbursement advice. Share this page: constat.dev/precedent/device/K220192