510(k) Report

Devices descending from K182901

3 later devices reach Aquilion Precision (TSX-304A/1 and /2) V8.8 with AiCE through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K220986Aquilion Precision (TSX-304A/4) V10.10 with AiCECanon Medical Systems Corporation20222—
+2K223726Aquilion Precision (TSX-304A/4) V10.14 with AiCECanon Medical Systems Corporation20231—
+3K243398CT Scanner TSX-501R/1 V11.1Canon Medical Systems Corporation20250—