510(k) Report

Devices descending from K043333

143 later devices reach VITREA2, Version 3.7 Medical Image Processing System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K171222Vitrea Software Toshiba Package; VSTP-001AToshibamedical Systems Corporation201712—
+6K160371NovaPACSNovarad Corporation20165—
+6K151988Visible Patient SuiteVisible Patient, Sas20154—
+6K130383Synapse 3D Cardiac ToolsFujifilm Medical System U.S.A., Inc.20135—
+7K253786syngo.CT Coronary CockpitSiemens Medical Solutions USA, Inc.20260—
+7K251656Careverse CoronaryDoc (Careverse CoronaryDoc)Careverse Technology Pte., Ltd.20250—
+7K251837Salix Coronary Plaque (V1.0.0)Artrya Limited20250—
+7K251766TumorSight VizSimBioSys, Inc.20250—
+7K244012Mosaic (V1.0.1)Navier Medical20250—
+7K242338Cleerly LABS (v2.0)Cleerly, Inc.20252—
+7K243881HeartSee™ Cardiac P.E.T. Processing Software For Myocardial Perfusion and Coronary Flow…Bracco Diagnostics, Inc.20250—
+7K230249IkshanaImmersivetouch20231—
+7K221870CarnaLife HoloMedapp S.A.20230—
+7K213215VSI HoloMedicineApoqlar GmbH20222—
+7K212896Visible Patient SuiteVisible Patient, Sas20213—
+7K202084DeepLook PRECISEDeeplook, Inc.20210—
+7K200973Synapse 3D Cardiac ToolsFujifilm Corporaton20204—
+7K192923Vitrea Software PackageCanon Medical Systems Corporation20208—
+7K171754NovaPACSNovarad Corporation201741
+8K261210Cleerly PlaqueCleerly, Inc.20260—
+8K260588Cleerly LABSCleerly, Inc.20260—
+8K253486SKIA-Head (Model: SKIA-ST00)Skia, Inc.20260—
+8K251577Laia XRAugmented Reality Software S.L.20260—
+8K250237InferOperate SuiteBeijing Infervision Healthcare Medical Technology Co., Ltd.20251—
+8K240094LumiNE US; LumiAugmedit B.V.20240—
+8K233457RUSHutom, Inc.20240—
+8K231662Aid-UIaid20241—
+8K221796Cyware 4H and Cysart 4HAbys Medical20221—
+8K220039AutoSegAi Medic, Inc.20221—
+8K220727inHEART MODELSInheart, Sas20221—
+8K203312Vitrea Software Package, VSTP-001ACanon Medical Systems Corporation20217—
+9K260973InferOperate SuiteBeijing Infervision Healthcare Medical Technology Co., Ltd.20260—
+9K250039HPACSHealthhub20250—
+9K243069Lumys (V1)Intradys20250—
+9K243158TeraRecon Aorta.CT (1.1.0)Terarecon,Inc.20250—
+9K231683inHEART ModelsInheart, Sas20240—
+9K213504Aquilion ONE (TSX-306A/3) V10.12 with Spectral Imaging System, Vitrea Software Package…Canon Medical Systems Corporation20226—
+10K232835Aquilion ONE (TSX-308A/3) V1.4 with PIQE Reconstruction SystemCanon Medical Systems Corporation20243—
+10K223336Vitrea Software Package, VSTP-002ACanon Medical Systems Corporation20231—
+11K242403Aquilion ONE (TSX-308A/3) V1.5Canon Medical Systems Corporation20242—
+11K240705Vitrea Software Package, VSTP-002A V2.0Canon Medical Systems Corporation20240—
+12K253596Aquilion ONE (TSX-308A/TSX-306A) V2.0Canon Medical Systems Corporation20260—
+12K251645Self-Propelled CT Scan Base Kit, CGBA-035A; Alphenix, INFX-8000C/B, INFX-8000C/S, V9.6…Canon Medical Systems Corporation20250—