Vantage Fortian/Orian 1.5T, MRT-1550, V9.0 with AiCE Reconstruction Processing Unit for MR

K240238

Canon Medical Systems Corporation · cleared 2024-04-12 · product code LNH · Radiology

Premarket evidence — what FDA accepted

Device typehardware with ml

source quote (p.7)

“The Vantage Fortian (Model MRT-1550/WK, WM, WO, WQ)/Vantage Orian (Model MRT-1550/ A3, A4, A7, A8) is a 1.5 Tesla Magnetic Resonance Imaging (MRI) System. These Vantage Fortian/Orian models use 1.4 m short and 4.1 tons light weight magnet. They include the Canon Pianissimo™™™ ∑ and Pianissimo Zen technology (scan noise reduction technology). The design of the gradient coil and the whole-body coil of these Vantage Fortian/Orian models provide the maximum field of view of 55 x 55 x 50 cm and include the standard gradient system. Iterative Motion Correction (IMC): IMC has been updated to utilize Deep Learning based methods in addition to traditional model-based methods. Free Breathing Dynamic: Free Breathing Dynamic is contrast enhanced dynamic imaging technique. Utilizing Deep Learning reconstruction, Free Breathing Dynamic enables a single continuous scan to aid patients who have difficulty holding their breath. Precise IQ Engine (PIQE): PIQE is Deep Learning based technique that generates higher in-plane matrix images from low matrix images while mitigating the ringing artifact. PIQE is targeted for brain and knee regions. NeuroLine+: NeuroLine+ has been updated to utilize Machine Learning based method.”

AlgorithmDeep Learning based methods, Deep Learning reconstruction, Deep Learning based technique, Machine Learning based method

source quote (p.7)

“Iterative Motion Correction (IMC): IMC has been updated to utilize Deep Learning based methods in addition to traditional model-based methods. Free Breathing Dynamic: Free Breathing Dynamic is contrast enhanced dynamic imaging technique. Utilizing Deep Learning reconstruction, Free Breathing Dynamic enables a single continuous scan to aid patients who have difficulty holding their breath. Precise IQ Engine (PIQE): PIQE is Deep Learning based technique that generates higher in-plane matrix images from low matrix images while mitigating the ringing artifact. PIQE is targeted for brain and knee regions. NeuroLine+: NeuroLine+ has been updated to utilize Machine Learning based method.”

Adaptive (vs locked)No

source quote (p.12)

“All testing data were acquired separately and independently from the training data after the machine learning training was completed.”

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 (5)

Reader study (MRMC)

n=36 patients · 2 site(s)

endpoints: SNR; image sharpness; image ringing; overall IQ; feature conspicuity

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), IEC62304-1 (2007, 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, 2018)

Retrospective clinical

n=15 cases

endpoints: successful scan alignment (offset and angle within acceptable error defined as typical inter-rater variability) greater than 80% of the time; accuracy of the auto-detected angle or center position of the target planes; angular error; auto-positioning success

Reader study (MRMC)

n=18 patients

endpoints: SNR; tissue contrast; image sharpness; diagnostic confidence; reducing motion artifacts

Retrospective clinical

n=11 cases

endpoints: 90.9% success (i.e., the automatically proposed phases included the gold standard phase as manually selected by experienced radiologists) which met the acceptance criteria (greater than or equal to 80%)

Reader study (MRMC)

n=29 cases

endpoints: overall SNR; overall IQ; feature conspicuity; diagnostic confidence

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
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
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).