510(k) Report

Devices descending from K122109

41 later devices reach Aquilion One Vision, V4.90 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K142697NExCT 7Neurologica Corporation20140—
+1K133324Suresubtraction LungToshiba Medical Systems Corporation, Japan20140—
+1K134025Aquilion One Vision Self-Propelled Scan Base Kit for Ivr-CTToshibamedical Systems Corporation20143—
+1K132222Aquilion One Vision, V6.0Toshibamedical Systems Corporation2013312
+1K130960Suresubtraction OrthoToshibamedical Systems Corporation20133—
+2K151212Ziostation2Qi Imaging, LLC20152—
+2K142736XIDF-AWS801, Angio Workstation, v5.31Toshibamedical Systems Corporation20156—
+2K142465Aquilion ONE Vision, v7.0Toshibamedical Systems Corporation2015221
+2K143223CGBA-032A, Aquilion PRIME Self-Propelled Scan Base Kit for IVR-CTToshibamedical Systems Corporation20152—
+2K133497Aquilion One VisionToshibamedical Systems Corporation201423—
+3K181892Ziostation2Ziosoft, Inc.20181—
+3K182223Aquilion ONE Self-Propelled Scan Base Kit for IVR-CT, CGBA-034ACanon Medical Systems, USA20181—
+3K160587Aquilion ONE (TSX-305A/3) V7.3Toshibamedical Systems Corporation201612—
+3K151673Aquilion ONE Vision with FIRST 1.0 (CCRS-001A)Toshibamedical Systems Corporation2015131
+3K151091Vitrea Software Toshiba Package, VSTP-001AToshibamedical Systems Corporation201513—
+3K150967XIDF-AWS801, Angio Workstation, V6.10Toshibamedical Systems Corporation201551
+4K251645Self-Propelled CT Scan Base Kit, CGBA-035A; Alphenix, INFX-8000C/B, INFX-8000C/S, V9.6…Canon Medical Systems Corporation20250—
+4K200315Ziostation2Ziosoft, Inc.20200—
+4K182601Vitrea Software Package, VSTP-001ACanon Medical Systems Corporation20180—
+4K183013Vitrea Software Package, VSTP-001ACanon Medical Systems Corporation20189—
+4K173088Vitrea Software Toshiba Package VSTP-001AToshibamedical Systems Corporation201811—
+4K170177Aquilion ONE (TSX-305A/3) V8.3 with FIRST 2.1Toshibamedical Systems Corporation2017111
+4K171222Vitrea Software Toshiba Package; VSTP-001AToshibamedical Systems Corporation201712—
+4K161009Aquilion ONE Vision with FIRST 2.0 (CCRS-001B) V7.4Toshibamedical Systems Corporation201612—
+4K152785XIDF-AWS801, Angio Workstation, V6.20Toshibamedical Systems Corporation201541
+5K192923Vitrea Software PackageCanon Medical Systems Corporation20208—
+5K183046Aquilion ONE (TSX-305A/6) V8.9 with AiCECanon Medical Systems Corporation201910—
+5K172646XIDF-AWS801, Angio Workstation, V7.0Toshibamedical Systems Corporation20173—
+6K203312Vitrea Software Package, VSTP-001ACanon Medical Systems Corporation20217—
+6K192188Aquilion ONE (TSX-306A/3) V10.0Canon Medical Systems Corporation20199—
+6K181415XIDF - AWS801, Angio Workstation (Alphenix Workstation), V8.0Canon Medical Systems Corporation20182—
+7K220342XIDF-AWS801, Angio Workstation (Alphenix Workstation), V9.3Canon Medical Systems Corporation20221—
+7K213504Aquilion ONE (TSX-306A/3) V10.12 with Spectral Imaging System, Vitrea Software Package…Canon Medical Systems Corporation20226—
+7K192828Aquilion ONE (TSX-306A/3) V10.0 with Spectral Imaging SystemCanon Medical Systems Corporation20208—
+8K232835Aquilion ONE (TSX-308A/3) V1.4 with PIQE Reconstruction SystemCanon Medical Systems Corporation20243—
+8K232526XIDF-AWS801, Angio Workstation (Alphenix Workstation), V9.5Canon Medical Systems Corporation20230—
+8K223336Vitrea Software Package, VSTP-002ACanon Medical Systems Corporation20231—
+8K203225Aquilion ONE (TSX-306A/3) V10.4 with Spectral Imaging SystemCanon Medical Systems Corporation20217—
+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—