Vantage Fortian/Orian 1.5T, MRT-1550, V10.0 with AiCE Reconstruction Processing Unit for MR

K250901

Canon Medical Systems Corporation · cleared 2025-07-22 · product code LNH · Radiology

Premarket evidence — what FDA accepted

Device typehardware with ml

source quote (p.8)

“Precise IQ Engine (PIQE): PIQE is a Deep Learning based technique that generates higher in-plane matrix images from low matrix images while mitigating the ringing artifact.”

AlgorithmDeep Learning based technique

source quote (p.8)

“Precise IQ Engine (PIQE): PIQE is a Deep Learning based technique that generates higher in-plane matrix images from low matrix images while mitigating the ringing artifact.”

Adaptive (vs locked)FDA source did not state this

PCCPFDA source did not state this

Cybersecurity addressedYes

source quote (p.12)

“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

n=1 other

endpoints: flow velocity of the 4DFlow sequence met the acceptance criteria

Bench

sample size not stated

endpoints: effective for suppressing wraparound artifacts in the PE direction; setting a smaller PE-FOV in Zoom DWI scan can reduce the image distortion level; ADC values can be measured accurately

Bench

sample size not stated

endpoints: Edge Slope Width (to evaluate image sharpness); Ringing Variable Mean (to evaluate ringing artifacts); Signal-to-Noise ratio; Contrast Ratio

Reader study (MRMC)

n=75 patients · 2 site(s)

endpoints: ringing; sharpness; SNR; overall image quality (IQ); feature conspicuity

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) 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
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).