510(k) Report

Devices descending from K945428

208 later devices reach Scribe (TM) Diagnostic Imaging Workstation through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K132853NovapacsNovarad Corp.201462
+6K141329RadspaTelerad Tech Private Limited20140—
+6K130552CT Pulmonary AnalysisQi Imaging, LLC20142—
+6K123944Kostec Medical Grade LDC MonitorsKostec Co., Ltd.20130—
+6K130383Synapse 3D Cardiac ToolsFujifilm Medical System U.S.A., Inc.20135—
+6K1123545MP Monochrome LCD Monitor, Radiforce GX530Eizo Nanao Corporation20113—
+6K11149621.3 Inch (54CM) Monochrome Digital Mammography LCD MonitorTotoku Electric Co., Ltd.20112—
+6K110071Cor AnalyzerRcadia Medical Imaging, Ltd.20114—
+6K09094721.3 (54 CM) Monochrome Digital Mammography LCD Monitor, Model MS3112 (MDL2128A)Totoku Electric Co., Ltd.20103—
+6K083084CT Brain Perfusion for ZiostationZiosoft, Inc.20080—
+6K082493Medical Display, MD205MG-1Nec Display Solutions, Ltd.20080—
+6K08124221.3 Inch (53CM) Monochrome Digital Mammography LCD Monitor MS51I2, (MDL2123A)Tokotu Electric Co., Ltd.20084—
+6K0804225 Megapixel Monochrome LCD Monitor, Model Radiforce GS520Eizo Nanao Corporation20081—
+6K07179415M Monochrome Digital Mammography LCD Monitor MDL2123A (MS51I2)Totoku Electric Co., Ltd.20084—
+6K072532Truepix LCD Medical Display Monitor, Models TX-5M, TX-3M, TX-2MDooyang Systems, Inc.20070—
+7K260497DEEPVESSEL PlaqueKeya Medical Technology Co., Ltd.20260—
+7K260167Bunkerhill Contrast AVCBunkerHill Health20260—
+7K252029AI-CVDHeartLung Corporation20250—
+7K251027cvi42 Coronary Plaque Software ApplicationCircle Cardiovascular Imaging, Inc.20250—
+7K243038Salix CentralArtrya Limited20251—
+7K243881HeartSee™ Cardiac P.E.T. Processing Software For Myocardial Perfusion and Coronary Flow…Bracco Diagnostics, Inc.20250—
+7K241922MyomicsPhantomics, Inc.20250—
+7K242240CaRi-PlaqueCaristo Diagnostics, Ltd.20251—
+7K2420621CMR ProMycardium AI Limited20240—
+7K241312TeraRecon Cardiac.Chambers.MR (1.0.0)Terarecon,Inc.20240—
+7K241847Imbio PHA (4.0.0)Imbio, Inc.20240—
+7K240620Cube NavigatorMedical Templates AG20240—
+7K223396Rapid RV/LVIschemaview, Inc.20231—
+7K221100Viz RV/LVViz. Ai, Inc.20224—
+7K220624AI4CMR v1.0Ai4medimaging Medical Solutions S.A.20222—
+7K221463ElucidVivo A.3Elucid Bioimaging, Inc.20221—
+7K212624EFAI Intelligent Cardiothoracic Ratio (iCTR) Assessment SystemEver Fortune.Ai, Co., Ltd.20223—
+7K211655aPROMISEExini Diagnostics AB20211—
+7K202280Cleerly Labs v2.0Cleerly, Inc.20205—
+7K200973Synapse 3D Cardiac ToolsFujifilm Corporaton20204—
+7K200315Ziostation2Ziosoft, Inc.20200—
+7K191530StoneCheckerImaging Biometrics, LLC20191—
+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—
+7K171303Added Screen Displays For FDA Cleared HeartSee Cardiac P.E.T Processing Software K143664University of Texas Medical School AT Houston, Texas20175—
+7K163232Vitrea ViewVital Images, Inc.20177—
+7K160371NovaPACSNovarad Corporation20165—
+7K151988Visible Patient SuiteVisible Patient, Sas20154—
+7K13113721.3 Inch Monochrome Digital Mammography LCD Monitor MS55I2 (ML21055, MD211G5)Jvckenwood Corporation20131—
+7K1204518MP Color LCD Monitor, Rediforce RX840Eizo Nanao Corporation20122—
+7K112145Monochrome Digital Mammography LCD Monitor MS33I2Totoku Electric Co., Ltd.20112—
+7K101796Pacsmate MMD-5201M MonitorIei Technology Corp.20100—
+7K08194521.3-Inch (54CM) Monochrome LCD Monitor MS21I2 (MDL2127A)Totoku Electric Co., Ltd.20083—
+8K253786syngo.CT Coronary CockpitSiemens Medical Solutions USA, Inc.20260—
+8K252084AI4CMR v2.0Ai4medimaging Medical Solutions S.A.20260—
+8K251656Careverse CoronaryDoc (Careverse CoronaryDoc)Careverse Technology Pte., Ltd.20250—
+8K251837Salix Coronary Plaque (V1.0.0)Artrya Limited20250—
+8K244012Mosaic (V1.0.1)Navier Medical20250—
+8K243378Rapid MLSIschemaview, Inc.20250—
+8K242338Cleerly LABS (v2.0)Cleerly, Inc.20252—
+8K232613CT CardiomegalyInnolitics, LLC20241—
+8K230534BriefCase-QuantificationAidoc Medical, Ltd.20233—
+8K231149qXR-CTRQure.Ai Technologies20230—
+8K220039AutoSegAi Medic, Inc.20221—
+8K220727inHEART MODELSInheart, Sas20221—
+8K220590aPROMISE XExini Diagnostics AB20220—
+8K212896Visible Patient SuiteVisible Patient, Sas20213—
+8K202679Optional Screen Display for HeartSee Cardiac P.E.T. Processing Software - HeartSee…Mcgovern Medical School20212—
+8K202084DeepLook PRECISEDeeplook, Inc.20210—
+8K192277CardIQ FlowGE Medical Systems SCS20200—
+8K192923Vitrea Software PackageCanon Medical Systems Corporation20208—
+8K190764SurgicalARMedivis, Inc.20196—
+8K181343HeartSee Cardiac P.E.T. Processing SoftwareBracco Diagnostics, Inc.20180—
+8K171754NovaPACSNovarad Corporation201741
+8K15100721.3 inch (54 cm) Color Digital Mammography LCD Monitor CCL550i2(CL21550)Jvckenwood Corporation20150—
+8K143718Mammography Color Display DP-M3010Canon, Inc.20150—
+8K1407028MP Color LCD Monitor, Radiforce RX850Eizo Corporation201401
+8K13368621.3 INCH (54 CM) INCH MONOCHROME DIGITAL MAMMOGRAPHY LCD MONITOR MS35i2 (ML21035)Jvckenwood Corporation20141—
+8K11344321.3 Inch (54 CM) Monochrome LCD Monitor MS23I2 (ML21023)Totoku Electric Co., Ltd.20112—
+9K261210Cleerly PlaqueCleerly, Inc.20260—
+9K260588Cleerly LABSCleerly, Inc.20260—
+9K250237InferOperate SuiteBeijing Infervision Healthcare Medical Technology Co., Ltd.20251—
+9K243859PRAEVAorta®2Nurea20250—
+9K243779Bunkerhill Abdominal Aortic Quantification (AAQ)BunkerHill Health20250—
+9K243158TeraRecon Aorta.CT (1.1.0)Terarecon,Inc.20250—
+9K233457RUSHutom, Inc.20240—
+9K241112BriefCase-QuantificationAidoc Medical, Ltd.20241—
+9K231683inHEART ModelsInheart, Sas20240—
+9K231662Aid-UIaid20241—
+9K230249IkshanaImmersivetouch20231—
+9K221870CarnaLife HoloMedapp S.A.20230—
+9K221796Cyware 4H and Cysart 4HAbys Medical20221—
+9K213215VSI HoloMedicineApoqlar GmbH20222—
+9K203312Vitrea Software Package, VSTP-001ACanon Medical Systems Corporation20217—
+9K2001613MP Monochrome Digital Mammography LCD Monitor MS-S300Jvckenwood Corporation20200—
+9K13351121.3 Inch (54 CM) Monochrome LCD Monitor MS25I2(ML21025)Jvckenwood Corporation20131—
+10K260973InferOperate SuiteBeijing Infervision Healthcare Medical Technology Co., Ltd.20260—
+10K253486SKIA-Head (Model: SKIA-ST00)Skia, Inc.20260—
+10K251577Laia XRAugmented Reality Software S.L.20260—
+10K250039HPACSHealthhub20250—
+10K243069Lumys (V1)Intradys20250—
+10K242203BriefCase-QuantificationAidoc Medical, Ltd.20240—
+10K240094LumiNE US; LumiAugmedit B.V.20240—