Vantage Orian 1.5T, MRT-1550, V6.0 with AiCE Reconstruction Processing Unit for MR
K193097Canon Medical Systems Corporation · cleared 2020-07-14 · product code LNH · Radiology
Premarket evidence — what FDA accepted
source quote (p.6)
“The Vantage Orian (Model MRT-1550) is a 1.5 Tesla Magnetic Resonance Imaging (MRI) System. The Vantage Orian uses 1.4 m short and 3.8 tons light weight magnet. It includes the Pianissimo™™ technology (scan noise reduction technology). The design of the gradient coil and the WB coil of the Vantage Orian 1.5T provides the maximum field of view of 55 x 55 x 50 cm. The Model MRT-1550/AC, AD, AG, AH includes the standard gradient system and Model MRT-1550/AK, AL, AO, AP includes the XGO gradient system. AICE is an optional noise reduction algorithm that improves image quality and reduces thermal noise by employing Deep Convolutional Neural Network methods.”
source quote (p.6)
“AICE is an optional noise reduction algorithm that improves image quality and reduces thermal noise by employing Deep Convolutional Neural Network methods.”
source quote (p.6)
“In order to train a DCNN that can learn a model that represents thermal noise, the training datasets are created by adding Gaussian noise of different amplitudes to high-SNR images acquired with large number of averages.”
Validation studies (3)
Bench
sample size not stated
endpoints: image low contrast detectability was maintained or improved
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), IEC62304 (2006), Amd.1 (2015), IEC62366 (2007), Amd.1 (2014), NEMA MS 1 (2008), NEMA MS 2 (2008), NEMA MS 3 (2008), NEMA MS 4 (2010), NEMA MS 5 (2010)
Reader study (MRMC)
n=160 images
endpoints: statistical preference of AiCE when compared to other performance filters
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), IEC62304 (2006), Amd.1 (2015), IEC62366 (2007), Amd.1 (2014), NEMA MS 1 (2008), NEMA MS 2 (2008), NEMA MS 3 (2008), NEMA MS 4 (2010), NEMA MS 5 (2010)
Bench
sample size not stated
endpoints: increase in SNR; maintained contrast
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), IEC62304 (2006), Amd.1 (2015), IEC62366 (2007), Amd.1 (2014), NEMA MS 1 (2008), NEMA MS 2 (2008), NEMA MS 3 (2008), NEMA MS 4 (2010), NEMA MS 5 (2010)
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) 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
- re_clearance
The FDA AI/ML device list shows a newer 510(k) K202767 (decision 2021-01-15) from Canon Medical Systems Corporation for a matching device line ("Vantage Orian 1.5T, MRT-1550, V6.0") — a new clearance for the same line is a change event.
first seen 2026-07-08 · k_number:K202767
- 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).