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Recognized a 510(k)/PMA number — showing its clearance record and devices.

Clearance record K203053

Vantage Orian 1.5T, MRT-1550, V7.0 with AiCE Reconstruction Processing Unit for MR · Canon Medical Systems Corporation · decided 2020-12-02 (SESE)

FDA 510(k) database ↗Summary PDF ↗

Devices

BrandModelCompanyProduct codesPrimary DI
Vantage OrianMRT-1550CANON INC.LNH04987670103360