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

by Canon Medical Systems Corporation 2 variants

510(k) K250901

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK250901 Date22 Jul 2025ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
LNH
Device Class
Class II
Regulation
21 CFR Part 892.1000
Advisory Committee
Radiology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 19 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Vantage Fortian/Orian 1.5T MRI System is a magnetic resonance imaging device designed for high-resolution anatomical and functional imaging. It incorporates an AiCE Reconstruction Processing Unit to enhance image quality and processing efficiency, supporting advanced diagnostic applications in radiology.

This system is intended for use in clinical, research, or hospital settings and is supplied as a reusable medical device. It operates within an MRI-safe environment and is cleared under FDA 510(k) as substantially equivalent to a predicate device, classified under product code LNH in FDA Class II. The device requires proper calibration, maintenance, and adherence to MRI safety protocols.

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