510(k) Report

Devices descending from K103465

20 later devices reach Synapse 3D Cardiac Tools through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K120636Synapse 3D Cardiac ToolsFujifilm Medical System U.S.A., Inc.201219—
+2K171222Vitrea Software Toshiba Package; VSTP-001AToshibamedical Systems Corporation201712—
+2K130383Synapse 3D Cardiac ToolsFujifilm Medical System U.S.A., Inc.20135—
+3K200973Synapse 3D Cardiac ToolsFujifilm Corporaton20204—
+3K182601Vitrea Software Package, VSTP-001ACanon Medical Systems Corporation20180—
+3K183013Vitrea Software Package, VSTP-001ACanon Medical Systems Corporation20189—
+3K173088Vitrea Software Toshiba Package VSTP-001AToshibamedical Systems Corporation201811—
+4K220039AutoSegAi Medic, Inc.20221—
+4K220727inHEART MODELSInheart, Sas20221—
+4K192923Vitrea Software PackageCanon Medical Systems Corporation20208—
+5K243158TeraRecon Aorta.CT (1.1.0)Terarecon,Inc.20250—
+5K231683inHEART ModelsInheart, Sas20240—
+5K203312Vitrea Software Package, VSTP-001ACanon 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—