510(k) Report

Devices descending from K945188

283 later devices reach Cemax Vipstation and/or Software through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K130552CT Pulmonary AnalysisQi Imaging, LLC20142—
+6K133357Charruapacs SystemCharruasoft SA20130—
+6K123944Kostec Medical Grade LDC MonitorsKostec Co., Ltd.20130—
+6K123584Syngo, CT Bone ReadingSiemens Medical Solutions USA, Inc.20138—
+6K123920Syngo.ViaSiemens AG Medical Solutions201363—
+6K123585Syngo, CT Cardiac FunctionSiemens Medical Solutions USA, Inc.201214—
+6K120718Instapacs/InstarispacsMeddiff Technologies Pvt., Ltd.20120—
+6K120361Synapse 3D Base ToolsFujifilm Medical Systems U.S.A, Inc.201213—
+6K112008Touchpacs SuiteTouch Medical Solutions, Inc.20120—
+6K112480View 1 ImagingKarl Storz Endoscopy America, Inc.20110—
+6K1123545MP Monochrome LCD Monitor, Radiforce GX530Eizo Nanao Corporation20113—
+6K11149621.3 Inch (54CM) Monochrome Digital Mammography LCD MonitorTotoku Electric Co., Ltd.20112—
+6K111319Ibis Explorer and Markup SoftwareMedqia20116—
+6K110844Symbia.NetSiemens Medical Solutions USA, Inc.20110—
+6K09094721.3 (54 CM) Monochrome Digital Mammography LCD Monitor, Model MS3112 (MDL2128A)Totoku Electric Co., Ltd.20103—
+6K093612Syngo.PlazaSiemens AG Medical Solutions20101016
+6K0937033DIShina Systems, Ltd.20102—
+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—
+7K254207AiORTA - Plan v2.0ViTAA Medical Solutions, Inc.20260—
+7K253735AV VascularPhilips Medical Systems Nederland B.V.20260—
+7K251766TumorSight VizSimBioSys, Inc.20250—
+7K243666uOmniscanShanghai United Imaging Healthcare Co., Ltd.20250—
+7K243703TechLiveDeepHealth, Inc.20250—
+7K243333rTOPRoclub GmbH20250—
+7K242329CT Collaboration LivePhilips Healthcare (Suzhou) Co., Ltd.20240—
+7K241981Change Healthcare Stratus Imaging PACSChange Healthcare Canada Company20240—
+7K242512ROCC ConsolePhilips Medical Systems Nederland B.V.20240—
+7K223261Open RibCanon Medical Informatics, Inc.20230—
+7K222476OmegaAI Image ViewerRamsoft, Inc.20223—
+7K220929ExcelsiorMerit Cro, Inc.20220—
+7K220349TeraRecon NeuroTerarecon,Inc.20220—
+7K220910Medical image processing softwareHangzhou Deepwise & League of PHD Technology Co., Ltd.20220—
+7K211655aPROMISEExini Diagnostics AB20211—
+7K203411syngo.CT Skull UnfoldingSiemens Medical Solutions USA, Inc.20210—
+7K203103Synapse 3D, Synapse 3D Base Tools v6.1Fujifilm Corporation20215—
+7K202229AI MetricsAi Metrics, LLC20200—
+7K201665Collaboration LivePhilips Ultrasound, Inc.20202—
+7K193267Al-Rad Companion (Musculoskeletal)Siemens Medical Solutions USA, Inc.20203—
+7K183268AI-Rad Companion (Cardiovascular)Siemens Medical Solutions USA, Inc.201911—
+7K183204Bone VCAR (BVCAR)GE Medical Systems SCS20191—
+7K173001uWS-CTShanghai United Imaging Healthcare Co., Ltd.20185—
+7K172999uWS-MRShanghai United Imaging Healthcare Co., Ltd.20184—
+7K181892Ziostation2Ziosoft, Inc.20181—
+7K181773Synapse 3D Optional ToolsFujifilm Corporation20180—
+7K172998uWS-MIShanghai United Imaging Healthcare Co., Ltd.20182—
+7K173625syngo.CT Clinical ExtensionsSiemens Medical Solutions USA, Inc.20185—
+7K171754NovaPACSNovarad Corporation201741
+7K170221syngo.CT Cardiac PlanningSiemens Healthcare GmbH201711
+7K151988Visible Patient SuiteVisible Patient, Sas20154—
+7K150843syngo®.via (version VB10A)Siemens AG201546—
+7K142316IMPAX AgilityAgfa Healthcare N.V.20151—
+7K141514Synapse 3D Tensor AnalysisFujifilm Meidcal Systems U.S.A.,Inc.20140—
+7K13113721.3 Inch Monochrome Digital Mammography LCD Monitor MS55I2 (ML21055, MD211G5)Jvckenwood Corporation20131—
+7K122205EXINIExini Diagnostics AB20125—
+7K1204518MP Color LCD Monitor, Rediforce RX840Eizo Nanao Corporation20122—
+7K112145Monochrome Digital Mammography LCD Monitor MS33I2Totoku Electric Co., Ltd.20112—
+7K1125303DI Including CscoreShina Systems, Ltd.20111—
+7K101666Syngo. Plaza VA20ASiemens AG Medical Solutions201093
+7K101796Pacsmate MMD-5201M MonitorIei Technology Corp.20100—
+7K08194521.3-Inch (54CM) Monochrome LCD Monitor MS21I2 (MDL2127A)Totoku Electric Co., Ltd.20083—
+8K254237Cci Pacs Viewer (Pacs-US-001)CliniComp, Intl.20260—
+8K252199AGFA HealthCare Enterprise ImagingAgfa Healthcare N.V.20250—
+8K241546aiCockpit AI ViewerFovia, Inc.20250—
+8K242362Lightning ViewerNexsys Electronics Inc. Dba Medweb20240—
+8K231662Aid-UIaid20241—
+8K223424Spine Auto ViewsGE Medical Systems SCS20230—
+8K222360AI-Rad Companion (Cardiovascular)Siemens Medical Solutions U.S.A.20230—
+8K221796Cyware 4H and Cysart 4HAbys Medical20221—
+8K221677Synapse 3D Base Tools v6.6Fujifilm Corporation20224—
+8K222361AI-Rad Companion (Musculoskeletal)Siemens Medical Solutions USA, Inc.20220—
+8K220590aPROMISE XExini Diagnostics AB20220—
+8K213944HealthOSTNanoxai, Ltd.20221—
+8K212896Visible Patient SuiteVisible Patient, Sas20213—
+8K212777Collaboration LivePhilips Ultrasound, Inc.20211—
+8K210085HealthCCSngZebra Medical Vision, Ltd.20219—
+8K192630uWS-MIShanghai United Imaging Healthcare Co., Ltd.20201—
+8K200315Ziostation2Ziosoft, Inc.20200—
+8K200515syngo.CT Cardiac PlanningSiemens Medical Soultions USA, Inc.20200—
+8K192402syngo.CT Extended FunctionalitySiemens Medical Solutions USA, Inc.20194—
+8K191262aBSIExini Diagnostics AB20192—
+8K183170uWS-CTShanghai United Imaging Healthcare Co., Ltd.20194—
+8K191040syngo.via (Version VB40A)Siemens Healthcare GmbH201910—
+8K183164uWS-MRShanghai United Imaging Healthcare Co., Ltd.20193—
+8K182208syngo.via View&GO (Version VA10A)Siemens Healthcare GmbH20184—
+8K173444Quantitative Total Extensible Imaging (QTxI)Aiq Solutions, Inc.20181—
+8K170952syngo.CT View&GOSiemens Medical Solutions USA, Inc.20173—
+8K163294syngo.MR General, syngo.MR Cardiology, syngo.MR NeurologySiemens Medical Solutions USA, Inc.201723—
+8K161685syngo®.via protoNeo (Version VA10A)Siemens Healthcare GmbH20161—
+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—
+8K132532Syngo.Plaza VB10ASiemens AG Healthcare2013811
+8K1134423DIShina Systems, Ltd.20120—
+8K11344321.3 Inch (54 CM) Monochrome LCD Monitor MS23I2 (ML21023)Totoku Electric Co., Ltd.20112—
+9K250039HPACSHealthhub20250—