510(k) Report

Devices descending from K142465

22 later devices reach Aquilion ONE Vision, v7.0 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K160587Aquilion ONE (TSX-305A/3) V7.3Toshibamedical Systems Corporation201612—
+1K151673Aquilion ONE Vision with FIRST 1.0 (CCRS-001A)Toshibamedical Systems Corporation2015131
+1K151091Vitrea Software Toshiba Package, VSTP-001AToshibamedical Systems Corporation201513—
+2K182601Vitrea Software Package, VSTP-001ACanon Medical Systems Corporation20180—
+2K183013Vitrea Software Package, VSTP-001ACanon Medical Systems Corporation20189—
+2K173088Vitrea Software Toshiba Package VSTP-001AToshibamedical Systems Corporation201811—
+2K170177Aquilion ONE (TSX-305A/3) V8.3 with FIRST 2.1Toshibamedical Systems Corporation2017111
+2K171222Vitrea Software Toshiba Package; VSTP-001AToshibamedical Systems Corporation201712—
+2K161009Aquilion ONE Vision with FIRST 2.0 (CCRS-001B) V7.4Toshibamedical Systems Corporation201612—
+3K192923Vitrea Software PackageCanon Medical Systems Corporation20208—
+3K183046Aquilion ONE (TSX-305A/6) V8.9 with AiCECanon Medical Systems Corporation201910—
+4K203312Vitrea Software Package, VSTP-001ACanon Medical Systems Corporation20217—
+4K192188Aquilion ONE (TSX-306A/3) V10.0Canon Medical Systems Corporation20199—
+5K213504Aquilion ONE (TSX-306A/3) V10.12 with Spectral Imaging System, Vitrea Software Package…Canon Medical Systems Corporation20226—
+5K192828Aquilion ONE (TSX-306A/3) V10.0 with Spectral Imaging SystemCanon Medical Systems Corporation20208—
+6K232835Aquilion ONE (TSX-308A/3) V1.4 with PIQE Reconstruction SystemCanon Medical Systems Corporation20243—
+6K223336Vitrea Software Package, VSTP-002ACanon Medical Systems Corporation20231—
+6K203225Aquilion ONE (TSX-306A/3) V10.4 with Spectral Imaging SystemCanon Medical Systems Corporation20217—
+7K242403Aquilion ONE (TSX-308A/3) V1.5Canon Medical Systems Corporation20242—
+7K240705Vitrea Software Package, VSTP-002A V2.0Canon Medical Systems Corporation20240—
+8K253596Aquilion ONE (TSX-308A/TSX-306A) V2.0Canon Medical Systems Corporation20260—
+8K251645Self-Propelled CT Scan Base Kit, CGBA-035A; Alphenix, INFX-8000C/B, INFX-8000C/S, V9.6…Canon Medical Systems Corporation20250—