Vantage Galan 3T, MRT-3020, V10.0 with AiCE Reconstruction Processing Unit for MR
K241496Canon Medical Systems Corporation · cleared 2024-08-20 · product code LNH · Radiology
Premarket evidence — what FDA accepted
source quote (p.1)
“Trade/Device Name: Vantage Galan 3T, MRT-3020, V10.0 with AiCE Reconstruction Processing Unit for MR Vantage Galan 3T systems are indicated for use as a diagnostic imaging modality that produces cross-sectional transaxial, coronal, sagittal, and oblique images that display anatomic structures of the head or body.”
source quote (p.10)
“Cybersecurity documentation, per the FDA cybersecurity premarket guidance document “Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions” issued on September 27, 2023, is also included as part of this submission.”
Validation studies (4)
Bench
sample size not stated
standards: ANSI AAMI ES60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 and A2:2010/(R)2012 (Cons. Text) [Incl. AMD2:2021], IEC60601-1:2005, A1:2012, A2:2020, IEC60601-1-2:2014+A1:2020, 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), ISO 10993-1 (2018), NEMA MS 1:2008 (R2020), NEMA MS 2:2008 (R2020), NEMA MS 3:2008 (R2020), NEMA MS 4 (2010), NEMA MS 5 (2010)
Bench
sample size not stated
endpoints: visualization of blood flow conditions; velocity measurement; velocity stream lines
Bench
sample size not stated
endpoints: suppressing wraparound artifacts; reducing image distortion; providing accurate ADC values
Bench
sample size not stated
endpoints: overall contrast; signal strength
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
- 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
- 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).