Premarket evidence — what FDA accepted

Device typehardware with ml

source quote (p.6)

“The Vantage Fortian (Model MRT-1550) is a 1.5 Tesla Magnetic Resonance Imaging (MRI) System. It includes the Canon Pianissimo™™ Σ and Pianissimo Zen technology (scan noise reduction technology). The design of the gradient coil and the whole body coil of the Vantage Fortian provides the maximum field of view of 55 x 55 x 50 cm. The Model MRT-1550/ WK, WM, WO, WQ includes the standard gradient system. LiverLine+: Machine Learning based detection technology for liver plane.”

AlgorithmMachine Learning based detection technology for features like LiverLine+, ProstateLine+, and W-SpineLine+, in addition to AiCE Reconstruction Processing Unit.

source quote (p.7)

“LiverLine+: Machine Learning based detection technology for liver plane.”

Adaptive (vs locked)FDA source did not state this

PCCPFDA source did not state this

Cybersecurity addressedFDA source did not state this

Validation studies (3)

Bench

sample size not stated

endpoints: system requirements; image quality

standards: ANSI AAMI ES60601-1:2005 / (R)2012 and A1:2012, IEC60601-1-2 (2014), IEC60601-1-6 (2010), Amd.1 (2013), IEC60601-2-33 (2010), Amd.1 (2013), Amd.2 (2015), IEC60825-1 (2007, 2014), IEC62304 (2006), Amd.1 (2015), IEC62366-1 (2020), NEMA MS 1 (2008), NEMA MS 2 (2008), NEMA MS 3 (2008), NEMA MS 4 (2010), NEMA MS 5 (2018)

Retrospective clinical

sample size not stated

endpoints: features worked as intended; diagnostic quality; reducing motion artifacts

standards: ANSI AAMI ES60601-1:2005 / (R)2012 and A1:2012, IEC60601-1-2 (2014), IEC60601-1-6 (2010), Amd.1 (2013), IEC60601-2-33 (2010), Amd.1 (2013), Amd.2 (2015), IEC60825-1 (2007, 2014), IEC62304 (2006), Amd.1 (2015), IEC62366-1 (2020), NEMA MS 1 (2008), NEMA MS 2 (2008), NEMA MS 3 (2008), NEMA MS 4 (2010), NEMA MS 5 (2018)

Bench

sample size not stated

endpoints: reduces artifacts; reduce distortion artifacts; CBF values met predetermined acceptance criteria

standards: ANSI AAMI ES60601-1:2005 / (R)2012 and A1:2012, IEC60601-1-2 (2014), IEC60601-1-6 (2010), Amd.1 (2013), IEC60601-2-33 (2010), Amd.1 (2013), Amd.2 (2015), IEC60825-1 (2007, 2014), IEC62304 (2006), Amd.1 (2015), IEC62366-1 (2020), NEMA MS 1 (2008), NEMA MS 2 (2008), NEMA MS 3 (2008), 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

100

recalls in product code, 24mo

510

MAUDE reports in code, 12mo

+5%

vs code's own 3-yr baseline

5

drift signals on this device

re_clearance
The FDA AI/ML device list shows a newer 510(k) K253625 (decision 2026-03-27) from Canon Medical Systems Corporation for a matching device line ("Vantage Fortian/Orian 1.5T, MRT-1550, 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:K253625
re_clearance
The FDA AI/ML device list shows a newer 510(k) K250901 (decision 2025-07-22) from Canon Medical Systems Corporation for a matching device line ("Vantage Fortian/Orian 1.5T, MRT-1550, 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:K250901
re_clearance
The FDA AI/ML device list shows a newer 510(k) K240238 (decision 2024-04-12) from Canon Medical Systems Corporation for a matching device line ("Vantage Fortian/Orian 1.5T, MRT-1550, 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:K240238
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).