DeviceClearance

Vantage Fortian/Orian 1.5T, MRT-1550, V10.0 with AiCE Reconstruction Processing Unit for MR— 510(k) K253625

Substantially Equivalent

Canon Medical Systems Corporation

FDA 510(k) clearance K253625 for Vantage Fortian/Orian 1.5T, MRT-1550, V10.0 with AiCE Reconstruction Processing Unit for MR, Substantially Equivalent on 2026-03-27. Applicant: Canon Medical Systems Corporation. Device class: 2.

Summary

Canon Medical Systems' record is for the Vantage Fortian/Orian 1.5T, MRT-1550, V10.0 with AiCE Reconstruction Processing Unit for MR. It's filed under LNH, nuclear magnetic resonance imaging systems, and the record doesn't describe it beyond that name and code name.

Class II, 21 CFR 892.1000. Radiology is both the classification panel and the review panel, and it came in as a Traditional 510(k).

Canon Medical Systems filed from Otawara-Shi, Japan. Review took 129 calendar days (November 18, 2025 to March 27, 2026).

Clearance details

Applicant
Canon Medical Systems Corporation
Product code
Product code LNH
Device class
Class 2
Regulation
21 CFR 892.1000
Advisory panel
Radiology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Otawara-Shi, JP
Download summary PDFView on FDA.gov ↗

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Adverse events under product code LNH

product code LNH
Death
11
Injury
670
Malfunction
1,460
Other
2
Total
2,143

Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.