Vantage Galan 3T, MRT-3020, V9.0 with AiCE Reconstruction Processing Unit for MR

K230355

Canon Medical Systems Corporation · cleared 2023-08-30 · product code LNH · Radiology

Premarket evidence — what FDA accepted

Device typehardware with ml

source quote (p.6)

“The Vantage Galan (Model MRT-3020) is a 3 Tesla Magnetic Resonance Imaging (MRI) System, previously cleared under K222387. This system is based upon the technology and materials of previously marketed Canon Medical Systems MRI systems and is intended to acquire and display cross-sectional transaxial, coronal, sagittal, and oblique images of anatomic structures of the head or body. ... Iterative Motion Correction (IMC): IMC has been updated to utilize Deep Learning based methods in addition to traditional model-based methods.”

AlgorithmDeep Learning based methods and Machine Learning based method

source quote (p.6)

“Iterative Motion Correction (IMC): IMC has been updated to utilize Deep Learning based methods in addition to traditional model-based methods. ... Free Breathing Dynamic: ...Utilizing Deep Learning reconstruction... ... Precise IQ Engine (PIQE): PIQE is Deep Learning based technique... ... NeuroLine+: NeuroLine+ has been updated to utilize Machine Learning based method.”

Adaptive (vs locked)FDA source did not state this

PCCPFDA source did not state this

Cybersecurity addressedYes

source quote (p.11)

“Software Documentation for a Moderate Level of Concern, per the FDA guidance document, “Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices Document" issued on May 11, 2005, is also included as part of this submission.”

Validation studies (18)

Bench

sample size not stated

standards: ANSI AAMI ES60601-1:2005/(R)2012 and A1:2012, IEC60601-1-2 (2020), IEC60601-1-6 (2010), Amd.1 (2013), Amd.2 (2020), IEC60601-2-33 (2010), Amd.1 (2013), Amd.2 (2015), IEC60825-1 (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

Retrospective clinical

sample size not stated

Bench

sample size not stated

Retrospective clinical

sample size not stated

Bench

sample size not stated

Bench

sample size not stated

Retrospective clinical

sample size not stated

Retrospective clinical

sample size not stated

Retrospective clinical

sample size not stated

Bench

sample size not stated

Reader study (MRMC)

n=17 patients

endpoints: ringing; sharpness; SNR; overall IQ; feature conspicuity

Retrospective clinical

n=13 cases

endpoints: successful scan alignment (offset and angle within acceptable error); auto-positioning success

Retrospective clinical

n=12 cases

endpoints: peak SNR; structural similarity (SSIM); reduction of motion artifacts

Reader study (MRMC)

n=300 images

endpoints: SNR; tissue contrast; image sharpness; diagnostic confidence

Retrospective clinical

n=34 images

endpoints: diagnostic information

Retrospective clinical

n=18 cases

endpoints: arterial phase detection success

Reader study (MRMC)

n=29 patients

endpoints: overall SNR; overall IQ; feature conspicuity; diagnostic confidence

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

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
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

Recall and MAUDE counts are product-code-level (reports aren't reliably attributable to one device). 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).