Vantage Fortian/Orian 1.5T, MRT-1550, V10.0 with AiCE Reconstruction Processing Unit for MR
K253625Canon Medical Systems Corporation · cleared 2026-03-27 · product code LNH · Radiology
Premarket evidence — what FDA accepted
source quote (p.7)
“The Vantage Fortian (Model MRT-1550/WK, WM, WO, WQ)/Vantage Orian (Model MRT-1550/U3, U4, U7, U8) is a 1.5 Tesla Magnetic Resonance Imaging (MRI) System.”
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 June 26, 2025, is also included as part of this submission.”
Validation studies (1)
Bench
sample size not stated
standards: ANSI AAMI ES 60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 and A2:2010/(R)2012 (Cons. Text) [Incl. AMD2:2021], IEC 60601-1:2005, A1:2012, A2:2020, IEC 60601-1-2:2014+A1:2020, IEC 60601-1-6 (2010), Amd.1 (2013), Amd.2 (2020), IEC 60601-2-33 (2010), Amd.1 (2013), Amd.2 (2015), IEC 60825-1 (2014), IEC 62304 (2006), Amd.1 (2015), IEC 62366-1 (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 (2018)
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
- 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).