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

K192574

Canon Medical Systems Corporation · cleared 2020-03-09 · 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 K181593. AICE is an optional noise reduction algorithm that improves image quality and reduces thermal noise by employing Deep Convolutional Neural Network methods.”

AlgorithmDeep Convolutional Neural Network methods

source quote (p.6)

“AICE is an optional noise reduction algorithm that improves image quality and reduces thermal noise by employing Deep Convolutional Neural Network methods.”

Adaptive (vs locked)No

source quote (p.6)

“In order to train a DCNN that can learn a model that represents thermal noise, the training datasets are created by adding Gaussian noise of different amplitudes to high-SNR images acquired with large number of averages.”

PCCPFDA source did not state this

Cybersecurity addressedYes

source quote (p.8)

“Risk Management activities for new software functionalities are included in this submission. The test methods used are the same as those submitted in the previously cleared submissions of the predicate device, Vantage Galan 3T, MRT-3020/A7, V5.0 (K181953). A declaration of conformity with design controls is included in this submission. IEC62304 (2006), Amd.1 (2015)”

Validation studies (2)

Bench

sample size not stated

endpoints: image Low Contrast Detectability was maintained or improved

standards: ANSI AAMI ES60601-1:2005/(R)2012 and A1:2012, IEC62304 (2006), Amd.1 (2015), IEC62366 (2007), Amd.1 (2014), IEC60601-1-2 (2014), NEMA MS 1 (2008), IEC60601-1-6 (2010), Amd.1 (2013), NEMA MS 2 (2008), IEC60601-2-33 (2010), Amd.1 (2013), Amd.2 (2015), NEMA MS 3 (2008), IEC60825-1 (2007), NEMA MS 4 (2010), NEMA MS 5 (2010), 21 CFR § 820, ISO 13485 Standards

Reader study (MRMC)

n=160 images

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

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
re_clearance
The FDA AI/ML device list shows a newer 510(k) K203323 (decision 2021-03-04) from Canon Medical Systems Corporation for a matching device line ("Vantage Galan 3T, MRT-3020, V6.0 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:K203323
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
…and 1 more.

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).