510(k) Report

Devices descending from K061326

25 later devices reach Voxar 3D Enterprise with Cardiametrix through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K103465Synapse 3D Cardiac ToolsFujifilm Medical Systems U.S.A, Inc.201120—
+1K070205ZiostationZiosoft, Inc.20073—
+2K151212Ziostation2Qi Imaging, LLC20152—
+2K120636Synapse 3D Cardiac ToolsFujifilm Medical System U.S.A., Inc.201219—
+3K181892Ziostation2Ziosoft, Inc.20181—
+3K171222Vitrea Software Toshiba Package; VSTP-001AToshibamedical Systems Corporation201712—
+3K130383Synapse 3D Cardiac ToolsFujifilm Medical System U.S.A., Inc.20135—
+4K200973Synapse 3D Cardiac ToolsFujifilm Corporaton20204—
+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—
+5K220039AutoSegAi Medic, Inc.20221—
+5K220727inHEART MODELSInheart, Sas20221—
+5K192923Vitrea Software PackageCanon Medical Systems Corporation20208—
+6K243158TeraRecon Aorta.CT (1.1.0)Terarecon,Inc.20250—
+6K231683inHEART ModelsInheart, Sas20240—
+6K203312Vitrea Software Package, VSTP-001ACanon 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—