510(k) Report

Devices descending from K023003

177 later devices reach Imagechecker-CT Workstation through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K141745Iqqa-Bodyimaging SoftwareEdda Technology20146—
+6K132853NovapacsNovarad Corp.201462
+6K141329RadspaTelerad Tech Private Limited20140—
+6K123646Emory Cardiac Toolbox 4.0Syntermed, Inc.20133—
+6K120636Synapse 3D Cardiac ToolsFujifilm Medical System U.S.A., Inc.201219—
+6K083084CT Brain Perfusion for ZiostationZiosoft, Inc.20080—
+7K260086CadAI-B DxBeamWorks, Inc.20260—
+7K260303See-Mode Augmented Reporting Tool, Breast (SMART-B)See-Mode Technologies Pty, Ltd.20260—
+7K260497DEEPVESSEL PlaqueKeya Medical Technology Co., Ltd.20260—
+7K251027cvi42 Coronary Plaque Software ApplicationCircle Cardiovascular Imaging, Inc.20250—
+7K251355X1-FFRSpectrawave, Inc.20250—
+7K242240CaRi-PlaqueCaristo Diagnostics, Ltd.20251—
+7K243189TumorSight VizSimBioSys, Inc.20241—
+7K240697See-Mode Augmented Reporting Tool, Thyroid (SMART-T)See-Mode Technologies Pte, Ltd.20240—
+7K232147CAAS WorkstationPie Medical Imaging BV20241—
+7K240620Cube NavigatorMedical Templates AG20240—
+7K231731Optional Screen Displays for HeartSee Cardiac P.E.T. Processing Software - HeartSee…Mcgovern Medical School20231—
+7K223422Emory Cardiac Toolbox 4.3Syntermed20230—
+7K221463ElucidVivo A.3Elucid Bioimaging, Inc.20221—
+7K220590aPROMISE XExini Diagnostics AB20220—
+7K202280Cleerly Labs v2.0Cleerly, Inc.20205—
+7K200315Ziostation2Ziosoft, Inc.20200—
+7K191530StoneCheckerImaging Biometrics, LLC20191—
+7K182611Qangio XA 3DMedis Medical Imaging Systems BV20194—
+7K190764SurgicalARMedivis, Inc.20196—
+7K180867AmCAD-UOAmcad Biomed Corporation20180—
+7K182601Vitrea Software Package, VSTP-001ACanon Medical Systems Corporation20180—
+7K183013Vitrea Software Package, VSTP-001ACanon Medical Systems Corporation20189—
+7K173088Vitrea Software Toshiba Package VSTP-001AToshibamedical Systems Corporation201811—
+7K171222Vitrea Software Toshiba Package; VSTP-001AToshibamedical Systems Corporation201712—
+7K160371NovaPACSNovarad Corporation20165—
+7K151988Visible Patient SuiteVisible Patient, Sas20154—
+7K130383Synapse 3D Cardiac ToolsFujifilm Medical System U.S.A., Inc.20135—
+8K253786syngo.CT Coronary CockpitSiemens Medical Solutions USA, Inc.20260—
+8K251656Careverse CoronaryDoc (Careverse CoronaryDoc)Careverse Technology Pte., Ltd.20250—
+8K251837Salix Coronary Plaque (V1.0.0)Artrya Limited20250—
+8K251766TumorSight VizSimBioSys, Inc.20250—
+8K244012Mosaic (V1.0.1)Navier Medical20250—
+8K243632uWS-Angio BasicShanghai United Imaging Healthcare Co., Ltd.20250—
+8K243769QFR (3.0)Qfr Solutions BV20250—
+8K242338Cleerly LABS (v2.0)Cleerly, Inc.20252—
+8K243881HeartSee™ Cardiac P.E.T. Processing Software For Myocardial Perfusion and Coronary Flow…Bracco Diagnostics, Inc.20250—
+8K230249IkshanaImmersivetouch20231—
+8K221870CarnaLife HoloMedapp S.A.20230—
+8K213215VSI HoloMedicineApoqlar GmbH20222—
+8K212896Visible Patient SuiteVisible Patient, Sas20213—
+8K210093AccuFFRangioArteryFlow Technology Co., Ltd.20212—
+8K202084DeepLook PRECISEDeeplook, Inc.20210—
+8K200973Synapse 3D Cardiac ToolsFujifilm Corporaton20204—
+8K192923Vitrea Software PackageCanon Medical Systems Corporation20208—
+8K171754NovaPACSNovarad Corporation201741
+9K261210Cleerly PlaqueCleerly, Inc.20260—
+9K260588Cleerly LABSCleerly, Inc.20260—
+9K253486SKIA-Head (Model: SKIA-ST00)Skia, Inc.20260—
+9K251577Laia XRAugmented Reality Software S.L.20260—
+9K250237InferOperate SuiteBeijing Infervision Healthcare Medical Technology Co., Ltd.20251—
+9K240094LumiNE US; LumiAugmedit B.V.20240—
+9K233457RUSHutom, Inc.20240—
+9K231662Aid-UIaid20241—
+9K230303AccuFFRangio PlusArteryFlow Technology Co., Ltd.20230—
+9K221711AccuICASArteryFlow Technology Co., Ltd.20230—
+9K221796Cyware 4H and Cysart 4HAbys Medical20221—
+9K220039AutoSegAi Medic, Inc.20221—
+9K220727inHEART MODELSInheart, Sas20221—
+9K203312Vitrea Software Package, VSTP-001ACanon Medical Systems Corporation20217—
+10K260973InferOperate SuiteBeijing Infervision Healthcare Medical Technology Co., Ltd.20260—
+10K250039HPACSHealthhub20250—
+10K243069Lumys (V1)Intradys20250—
+10K243158TeraRecon Aorta.CT (1.1.0)Terarecon,Inc.20250—
+10K231683inHEART ModelsInheart, Sas20240—
+10K213504Aquilion ONE (TSX-306A/3) V10.12 with Spectral Imaging System, Vitrea Software Package…Canon Medical Systems Corporation20226—
+11K232835Aquilion ONE (TSX-308A/3) V1.4 with PIQE Reconstruction SystemCanon Medical Systems Corporation20243—
+11K223336Vitrea Software Package, VSTP-002ACanon Medical Systems Corporation20231—
+12K242403Aquilion ONE (TSX-308A/3) V1.5Canon Medical Systems Corporation20242—
+12K240705Vitrea Software Package, VSTP-002A V2.0Canon Medical Systems Corporation20240—
+13K253596Aquilion ONE (TSX-308A/TSX-306A) V2.0Canon Medical Systems Corporation20260—
+13K251645Self-Propelled CT Scan Base Kit, CGBA-035A; Alphenix, INFX-8000C/B, INFX-8000C/S, V9.6…Canon Medical Systems Corporation20250—