510(k) Report

Devices descending from K141741

18 later devices reach Aquilion Prime, V6.00 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K173468Aquilion Precision (TSX-304A/2) V8.6 with FIRST 3.0Toshibamedical Systems Corporation201841
+1K172188Aquilion Prime SP, TSX-303B/1, v8.4Toshiba Medical Systems Coroporation201731
+1K170019Aquilion Lightning, TSX-036A/1, V8.4Toshibamedical Systems Corporation201791
+1K143223CGBA-032A, Aquilion PRIME Self-Propelled Scan Base Kit for IVR-CTToshibamedical Systems Corporation20152—
+2K201836Aquilion Lightning (TSX-036A/7) V10.2 with AiCE-iCanon Medical Systems Corporation20214—
+2K192832Aquilion Prime SP (TSX-303B8) V10.2 with AiCE-iCanon Medical Systems Corporation202021
+2K182901Aquilion Precision (TSX-304A/1 and /2) V8.8 with AiCECanon Medical Systems Corporation20193—
+2K182223Aquilion ONE Self-Propelled Scan Base Kit for IVR-CT, CGBA-034ACanon Medical Systems, USA20181—
+3K251645Self-Propelled CT Scan Base Kit, CGBA-035A; Alphenix, INFX-8000C/B, INFX-8000C/S, V9.6…Canon Medical Systems Corporation20250—
+3K222819Aquilion Serve (TSX-307A/1) V1.2 with AiCE-iCanon Medical Systems Corporation20233—
+3K220986Aquilion Precision (TSX-304A/4) V10.10 with AiCECanon Medical Systems Corporation20222—
+3K203042Aquilion Exceed LB (TSX-202A/3) V10.6 with AiCE-ICanon Medical Systems Corporation20201—
+4K231281Aquilion Serve (TSX-307A/1) V1.3Canon Medical Systems Corporation20232—
+4K223726Aquilion Precision (TSX-304A/4) V10.14 with AiCECanon Medical Systems Corporation20231—
+4K211828Aquilion Exceed LBCanon Medical Systems Corporation20210—
+5K243398CT Scanner TSX-501R/1 V11.1Canon Medical Systems Corporation20250—
+5K233334Aquilion Serve SP (TSX-307B/1) V1.3Canon Medical Systems Corporation20231—
+6K260078Aquilion ServeSP (TSX-307B) V2.0Canon Medical Systems Corporation20260—