510(k) Report

Devices descending from K232835

3 later devices reach Aquilion ONE (TSX-308A/3) V1.4 with PIQE Reconstruction System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K242403Aquilion ONE (TSX-308A/3) V1.5Canon Medical Systems Corporation20242—
+2K253596Aquilion ONE (TSX-308A/TSX-306A) V2.0Canon Medical Systems Corporation20260—
+2K251645Self-Propelled CT Scan Base Kit, CGBA-035A; Alphenix, INFX-8000C/B, INFX-8000C/S, V9.6…Canon Medical Systems Corporation20250—