510(k) Report

Devices descending from K193097

3 later devices reach Vantage Orian 1.5T, MRT-1550, V6.0 with AiCE Reconstruction Processing Unit… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K202767Vantage Orian 1.5T, MRT-1550, V6.0Canon Medical Systems Corporation20211—
+1K203053Vantage Orian 1.5T, MRT-1550, V7.0 with AiCE Reconstruction Processing Unit for MRCanon Medical Systems Corporation20200—
+2K210340Vantage Orian 1.5T, MRT-1550, V6.0 with AiCE Reconstruction Processing Unit for MRCanon Medical Systems Corporation20210—