FDA 510(k)

Vantage Fortian/Orian 1.5T, MRT-1550, V10.0 com Unidade de Processamento de Reconstrução AiCE para RM

Número K: K253625 · 2026-03-27

RequerenteCanon Medical Systems Corporation

Data da decisão2026-03-27

Código do produtoLNH

Comité consultivoA Política: medical-regulatory-v1 RA A Política: medical-regulatory-v1 RA

DecisãoSubstancialmente equivalente

Resumo do dispositivo

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.

Perguntas frequentes

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.

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