510(k) Report

Devices descending from K990426

166 later devices reach Calcium Scoring through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K220624AI4CMR v1.0Ai4medimaging Medical Solutions S.A.20222—
+5K221463ElucidVivo A.3Elucid Bioimaging, Inc.20221—
+5K212624EFAI Intelligent Cardiothoracic Ratio (iCTR) Assessment SystemEver Fortune.Ai, Co., Ltd.20223—
+5K211655aPROMISEExini Diagnostics AB20211—
+5K202280Cleerly Labs v2.0Cleerly, Inc.20205—
+5K200973Synapse 3D Cardiac ToolsFujifilm Corporaton20204—
+5K200315Ziostation2Ziosoft, Inc.20200—
+5K191530StoneCheckerImaging Biometrics, LLC20191—
+5K180867AmCAD-UOAmcad Biomed Corporation20180—
+5K182601Vitrea Software Package, VSTP-001ACanon Medical Systems Corporation20180—
+5K183013Vitrea Software Package, VSTP-001ACanon Medical Systems Corporation20189—
+5K173088Vitrea Software Toshiba Package VSTP-001AToshibamedical Systems Corporation201811—
+5K171303Added Screen Displays For FDA Cleared HeartSee Cardiac P.E.T Processing Software K143664University of Texas Medical School AT Houston, Texas20175—
+5K163232Vitrea ViewVital Images, Inc.20177—
+5K160371NovaPACSNovarad Corporation20165—
+5K151988Visible Patient SuiteVisible Patient, Sas20154—
+6K253786syngo.CT Coronary CockpitSiemens Medical Solutions USA, Inc.20260—
+6K252084AI4CMR v2.0Ai4medimaging Medical Solutions S.A.20260—
+6K251656Careverse CoronaryDoc (Careverse CoronaryDoc)Careverse Technology Pte., Ltd.20250—
+6K251837Salix Coronary Plaque (V1.0.0)Artrya Limited20250—
+6K244012Mosaic (V1.0.1)Navier Medical20250—
+6K243378Rapid MLSIschemaview, Inc.20250—
+6K242338Cleerly LABS (v2.0)Cleerly, Inc.20252—
+6K232613CT CardiomegalyInnolitics, LLC20241—
+6K230534BriefCase-QuantificationAidoc Medical, Ltd.20233—
+6K231149qXR-CTRQure.Ai Technologies20230—
+6K220039AutoSegAi Medic, Inc.20221—
+6K220727inHEART MODELSInheart, Sas20221—
+6K220590aPROMISE XExini Diagnostics AB20220—
+6K212896Visible Patient SuiteVisible Patient, Sas20213—
+6K202679Optional Screen Display for HeartSee Cardiac P.E.T. Processing Software - HeartSee…Mcgovern Medical School20212—
+6K202084DeepLook PRECISEDeeplook, Inc.20210—
+6K192277CardIQ FlowGE Medical Systems SCS20200—
+6K192923Vitrea Software PackageCanon Medical Systems Corporation20208—
+6K190764SurgicalARMedivis, Inc.20196—
+6K181343HeartSee Cardiac P.E.T. Processing SoftwareBracco Diagnostics, Inc.20180—
+6K171754NovaPACSNovarad Corporation201741
+7K261210Cleerly PlaqueCleerly, Inc.20260—
+7K260588Cleerly LABSCleerly, Inc.20260—
+7K250237InferOperate SuiteBeijing Infervision Healthcare Medical Technology Co., Ltd.20251—
+7K243859PRAEVAorta®2Nurea20250—
+7K243779Bunkerhill Abdominal Aortic Quantification (AAQ)BunkerHill Health20250—
+7K243158TeraRecon Aorta.CT (1.1.0)Terarecon,Inc.20250—
+7K233457RUSHutom, Inc.20240—
+7K241112BriefCase-QuantificationAidoc Medical, Ltd.20241—
+7K231683inHEART ModelsInheart, Sas20240—
+7K231662Aid-UIaid20241—
+7K230249IkshanaImmersivetouch20231—
+7K221870CarnaLife HoloMedapp S.A.20230—
+7K221796Cyware 4H and Cysart 4HAbys Medical20221—
+7K213215VSI HoloMedicineApoqlar GmbH20222—
+7K203312Vitrea Software Package, VSTP-001ACanon Medical Systems Corporation20217—
+8K260973InferOperate SuiteBeijing Infervision Healthcare Medical Technology Co., Ltd.20260—
+8K253486SKIA-Head (Model: SKIA-ST00)Skia, Inc.20260—
+8K251577Laia XRAugmented Reality Software S.L.20260—
+8K250039HPACSHealthhub20250—
+8K243069Lumys (V1)Intradys20250—
+8K242203BriefCase-QuantificationAidoc Medical, Ltd.20240—
+8K240094LumiNE US; LumiAugmedit B.V.20240—
+8K213504Aquilion ONE (TSX-306A/3) V10.12 with Spectral Imaging System, Vitrea Software Package…Canon Medical Systems Corporation20226—
+9K232835Aquilion ONE (TSX-308A/3) V1.4 with PIQE Reconstruction SystemCanon Medical Systems Corporation20243—
+9K223336Vitrea Software Package, VSTP-002ACanon Medical Systems Corporation20231—
+10K242403Aquilion ONE (TSX-308A/3) V1.5Canon Medical Systems Corporation20242—
+10K240705Vitrea Software Package, VSTP-002A V2.0Canon Medical Systems Corporation20240—
+11K253596Aquilion ONE (TSX-308A/TSX-306A) V2.0Canon Medical Systems Corporation20260—
+11K251645Self-Propelled CT Scan Base Kit, CGBA-035A; Alphenix, INFX-8000C/B, INFX-8000C/S, V9.6…Canon Medical Systems Corporation20250—