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. 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. AICE is an optional noise reduction algorithm that improves image quality and reduces thermal noise by employing Deep Convolutional Neural Network methods. This software and its associated hardware are used on Canon MRI systems that are designed to communicate with the AiCE Reconstruction Processing Unit for MR.”
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)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

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), ISO 13485 Standards

Reader study (MRMC)

n=160 images

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

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), ISO 13485 Standards

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
7
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.

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/K192574