510(k) Report

Devices descending from K170019

9 later devices reach Aquilion Lightning, TSX-036A/1, V8.4 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K201836Aquilion Lightning (TSX-036A/7) V10.2 with AiCE-iCanon Medical Systems Corporation20214—
+1K172188Aquilion Prime SP, TSX-303B/1, v8.4Toshiba Medical Systems Coroporation201731
+2K222819Aquilion Serve (TSX-307A/1) V1.2 with AiCE-iCanon Medical Systems Corporation20233—
+2K192832Aquilion Prime SP (TSX-303B8) V10.2 with AiCE-iCanon Medical Systems Corporation202021
+3K231281Aquilion Serve (TSX-307A/1) V1.3Canon Medical Systems Corporation20232—
+3K203042Aquilion Exceed LB (TSX-202A/3) V10.6 with AiCE-ICanon Medical Systems Corporation20201—
+4K233334Aquilion Serve SP (TSX-307B/1) V1.3Canon Medical Systems Corporation20231—
+4K211828Aquilion Exceed LBCanon Medical Systems Corporation20210—
+5K260078Aquilion ServeSP (TSX-307B) V2.0Canon Medical Systems Corporation20260—