510(k) Report

Devices descending from K172188

3 later devices reach Aquilion Prime SP, TSX-303B/1, v8.4 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K192832Aquilion Prime SP (TSX-303B8) V10.2 with AiCE-iCanon Medical Systems Corporation202021
+2K203042Aquilion Exceed LB (TSX-202A/3) V10.6 with AiCE-ICanon Medical Systems Corporation20201—
+3K211828Aquilion Exceed LBCanon Medical Systems Corporation20210—