510(k) Report

Devices descending from K151673

13 later devices reach Aquilion ONE Vision with FIRST 1.0 (CCRS-001A) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K161009Aquilion ONE Vision with FIRST 2.0 (CCRS-001B) V7.4Toshibamedical Systems Corporation201612—
+2K170177Aquilion ONE (TSX-305A/3) V8.3 with FIRST 2.1Toshibamedical Systems Corporation2017111
+3K183046Aquilion ONE (TSX-305A/6) V8.9 with AiCECanon Medical Systems Corporation201910—
+4K192188Aquilion ONE (TSX-306A/3) V10.0Canon Medical Systems Corporation20199—
+5K192828Aquilion ONE (TSX-306A/3) V10.0 with Spectral Imaging SystemCanon Medical Systems Corporation20208—
+6K203225Aquilion ONE (TSX-306A/3) V10.4 with Spectral Imaging SystemCanon Medical Systems Corporation20217—
+7K213504Aquilion ONE (TSX-306A/3) V10.12 with Spectral Imaging System, Vitrea Software Package…Canon Medical Systems Corporation20226—
+8K232835Aquilion ONE (TSX-308A/3) V1.4 with PIQE Reconstruction SystemCanon Medical Systems Corporation20243—
+8K223336Vitrea Software Package, VSTP-002ACanon Medical Systems Corporation20231—
+9K242403Aquilion ONE (TSX-308A/3) V1.5Canon Medical Systems Corporation20242—
+9K240705Vitrea Software Package, VSTP-002A V2.0Canon Medical Systems Corporation20240—
+10K253596Aquilion ONE (TSX-308A/TSX-306A) V2.0Canon Medical Systems Corporation20260—
+10K251645Self-Propelled CT Scan Base Kit, CGBA-035A; Alphenix, INFX-8000C/B, INFX-8000C/S, V9.6…Canon Medical Systems Corporation20250—