510(k) Report

Devices descending from K183046

10 later devices reach Aquilion ONE (TSX-305A/6) V8.9 with AiCE through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K192188Aquilion ONE (TSX-306A/3) V10.0Canon Medical Systems Corporation20199—
+2K192828Aquilion ONE (TSX-306A/3) V10.0 with Spectral Imaging SystemCanon Medical Systems Corporation20208—
+3K203225Aquilion ONE (TSX-306A/3) V10.4 with Spectral Imaging SystemCanon Medical Systems Corporation20217—
+4K213504Aquilion ONE (TSX-306A/3) V10.12 with Spectral Imaging System, Vitrea Software Package…Canon Medical Systems Corporation20226—
+5K232835Aquilion ONE (TSX-308A/3) V1.4 with PIQE Reconstruction SystemCanon Medical Systems Corporation20243—
+5K223336Vitrea Software Package, VSTP-002ACanon Medical Systems Corporation20231—
+6K242403Aquilion ONE (TSX-308A/3) V1.5Canon Medical Systems Corporation20242—
+6K240705Vitrea Software Package, VSTP-002A V2.0Canon Medical Systems Corporation20240—
+7K253596Aquilion ONE (TSX-308A/TSX-306A) V2.0Canon Medical Systems Corporation20260—
+7K251645Self-Propelled CT Scan Base Kit, CGBA-035A; Alphenix, INFX-8000C/B, INFX-8000C/S, V9.6…Canon Medical Systems Corporation20250—