FDA 510(k)

Vantage Fortian/Orian 1.5T, MRT-1550, V10.0 配备 AiCE 重建处理单元的核磁共振成像设备

K号: K253625 · 2026-03-27

决定日期2026-03-27

产品代码LNH

咨询委员会RA

决定实质等同

器械摘要

Vantage Fortian/Orian 1.5T, MRT-1550, V10.0 with AiCE Reconstruction Processing Unit for MR is the device name listed in this FDA 510(k) record. The listed applicant is Canon Medical Systems Corporation. It received FDA 510(k) clearance on 2026-03-27 under 510(k) number K253625. The device is classified under product code LNH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常见问题

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

Vantage Fortian/Orian 1.5T, MRT-1550, V10.0 with AiCE Reconstruction Processing Unit for MR is a medical device that received FDA 510(k) clearance on 2026-03-27. The listed applicant is Canon Medical Systems Corporation. The 510(k) number is K253625.

When did Vantage Fortian/Orian 1.5T, MRT-1550, V10.0 with AiCE Reconstruction Processing Unit for MR receive FDA 510(k) clearance?

Vantage Fortian/Orian 1.5T, MRT-1550, V10.0 with AiCE Reconstruction Processing Unit for MR received FDA 510(k) clearance on 2026-03-27, under 510(k) number K253625.

Who is the listed applicant for Vantage Fortian/Orian 1.5T, MRT-1550, V10.0 with AiCE Reconstruction Processing Unit for MR?

The FDA 510(k) record lists Canon Medical Systems Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Vantage Fortian/Orian 1.5T, MRT-1550, V10.0 with AiCE Reconstruction Processing Unit for MR?

The FDA product code for Vantage Fortian/Orian 1.5T, MRT-1550, V10.0 with AiCE Reconstruction Processing Unit for MR is LNH.

列明Canon Medical Systems Corporation为申报人的其他记录

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

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