510(k) Report

Devices descending from K160587

12 later devices reach Aquilion ONE (TSX-305A/3) V7.3 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K170177Aquilion ONE (TSX-305A/3) V8.3 with FIRST 2.1Toshibamedical Systems Corporation2017111
+2K183046Aquilion ONE (TSX-305A/6) V8.9 with AiCECanon Medical Systems Corporation201910—
+3K192188Aquilion ONE (TSX-306A/3) V10.0Canon Medical Systems Corporation20199—
+4K192828Aquilion ONE (TSX-306A/3) V10.0 with Spectral Imaging SystemCanon Medical Systems Corporation20208—
+5K203225Aquilion ONE (TSX-306A/3) V10.4 with Spectral Imaging SystemCanon Medical Systems Corporation20217—
+6K213504Aquilion ONE (TSX-306A/3) V10.12 with Spectral Imaging System, Vitrea Software Package…Canon Medical Systems Corporation20226—
+7K232835Aquilion ONE (TSX-308A/3) V1.4 with PIQE Reconstruction SystemCanon Medical Systems Corporation20243—
+7K223336Vitrea Software Package, VSTP-002ACanon Medical Systems Corporation20231—
+8K242403Aquilion ONE (TSX-308A/3) V1.5Canon Medical Systems Corporation20242—
+8K240705Vitrea Software Package, VSTP-002A V2.0Canon Medical Systems Corporation20240—
+9K253596Aquilion ONE (TSX-308A/TSX-306A) V2.0Canon Medical Systems Corporation20260—
+9K251645Self-Propelled CT Scan Base Kit, CGBA-035A; Alphenix, INFX-8000C/B, INFX-8000C/S, V9.6…Canon Medical Systems Corporation20250—