Vantage Galan 3T, MRT-3020, V6.0 with AiCE Reconstruction Processing Unit for MR

K203323

Canon Medical Systems Corporation · cleared 2021-03-04 · 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 K192574. 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. The AiCE Reconstruction Processing Unit for MR is included with this system for the processing of images for various anatomical regions. This submission is a modification that expands the clinical regions for the AiCE Deep Learning Reconstruction.”

AlgorithmDeep Learning Reconstruction

source quote (p.7)

“This submission is a modification that expands the clinical regions for the AiCE Deep Learning Reconstruction.”

Adaptive (vs locked)FDA source did not state this

PCCPFDA source did not state this

Cybersecurity addressedFDA source did not state this

Validation studies (2)

Bench

sample size not stated

endpoints: image low contrast detectability was maintained or improved; SNR and contrast performance

standards: 21 CFR § 820, ISO 13485

Reader study (MRMC)

n=348 scans

endpoints: statistical preference of AiCE when compared to other performance filters

standards: 21 CFR § 820, ISO 13485

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
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
re_clearance
The FDA AI/ML device list shows a newer 510(k) K220192 (decision 2022-04-08) from Canon Medical Systems Corporation for a matching device line ("Vantage Galan 3T, MRT-3020, V8.0 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:K220192
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).