510(k) Report

Devices descending from K994329

208 later devices reach Iivs Integrated Image Viewing Station through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K242362Lightning ViewerNexsys Electronics Inc. Dba Medweb20240—
+6K231662Aid-UIaid20241—
+6K223424Spine Auto ViewsGE Medical Systems SCS20230—
+6K222360AI-Rad Companion (Cardiovascular)Siemens Medical Solutions U.S.A.20230—
+6K221796Cyware 4H and Cysart 4HAbys Medical20221—
+6K221677Synapse 3D Base Tools v6.6Fujifilm Corporation20224—
+6K222361AI-Rad Companion (Musculoskeletal)Siemens Medical Solutions USA, Inc.20220—
+6K220590aPROMISE XExini Diagnostics AB20220—
+6K213944HealthOSTNanoxai, Ltd.20221—
+6K212896Visible Patient SuiteVisible Patient, Sas20213—
+6K212777Collaboration LivePhilips Ultrasound, Inc.20211—
+6K210085HealthCCSngZebra Medical Vision, Ltd.20219—
+6K192630uWS-MIShanghai United Imaging Healthcare Co., Ltd.20201—
+6K200315Ziostation2Ziosoft, Inc.20200—
+6K200515syngo.CT Cardiac PlanningSiemens Medical Soultions USA, Inc.20200—
+6K192402syngo.CT Extended FunctionalitySiemens Medical Solutions USA, Inc.20194—
+6K191262aBSIExini Diagnostics AB20192—
+6K183170uWS-CTShanghai United Imaging Healthcare Co., Ltd.20194—
+6K191040syngo.via (Version VB40A)Siemens Healthcare GmbH201910—
+6K183164uWS-MRShanghai United Imaging Healthcare Co., Ltd.20193—
+6K182208syngo.via View&GO (Version VA10A)Siemens Healthcare GmbH20184—
+6K173444Quantitative Total Extensible Imaging (QTxI)Aiq Solutions, Inc.20181—
+6K170952syngo.CT View&GOSiemens Medical Solutions USA, Inc.20173—
+6K163294syngo.MR General, syngo.MR Cardiology, syngo.MR NeurologySiemens Medical Solutions USA, Inc.201723—
+6K161685syngo®.via protoNeo (Version VA10A)Siemens Healthcare GmbH20161—
+6K132532Syngo.Plaza VB10ASiemens AG Healthcare2013811
+6K1134423DIShina Systems, Ltd.20120—
+7K250039HPACSHealthhub20250—
+7K250237InferOperate SuiteBeijing Infervision Healthcare Medical Technology Co., Ltd.20251—
+7K243647Synapse PACS (7.5)FUJIFILM Healthcare Americas Corporation20251—
+7K250443MAGNETOM Avanto Fit; MAGNETOM Skyra Fit; MAGNETOM Sola Fit; MAGNETOM Viato.MobileSiemens Healthcare GmbH20252Class I
+7K243762Synapse 3D Base Tools (V7.0)Fujifilm Corporation20251—
+7K243632uWS-Angio BasicShanghai United Imaging Healthcare Co., Ltd.20250—
+7K243069Lumys (V1)Intradys20250—
+7K240411uAI PortalShanghai United Imaging Intelligence Co., Ltd.20240—
+7K233998TRAQinform IQAiq Global, Inc.20240—
+7K241302SonoSyncSamsung Medison Co., Ltd.20240—
+7K241440HealthCCSngNano-X AI, Ltd.20240—
+7K233457RUSHutom, Inc.20240—
+7K233209uOmnispace.CTShanghai United Imaging Healthcare Co., Ltd.20241—
+7K233080HealthFLDNano-X AI, Ltd.20240—
+7K233176uOmnispace.MIShanghai United Imaging Healthcare Co., Ltd.20230—
+7K231631BriefCase-QuantificationAidoc Medical, Ltd.20230—
+7K230039uOmnispaceShanghai United Imaging Healthcare Co., Ltd.20230—
+7K230112CAC SoftwareImbio, Inc.20230—
+7K230223iCAC DeviceBunkerhill, Inc.20236—
+7K213665Syngo Carbon Space VA20ASiemens Healthcare GmbH20225—
+7K203699syngo. CT Extended FunctionalitiesSiemens Medical Solutions USA, Inc.20213—
+7K201948AcroDTI VisualizerAcroviz, Inc.20200—
+7K201477syngo.via View&GOSiemens Healthcare GmbH20203—
+7K192601uWS-MRShanghai United Imaging Healthcare Co., Ltd.20202—
+7K183272AI Rad Companion (Engine)Siemens Medical Solutions USA, Inc.20192—
+7K180563syngo.plazaSiemens Healthcare GmbH20180—
+7K180336syngo.MR ApplicationsSiemens Medical Solutions USA, Inc.201821—
+7K173378syngo®.via protoNeo (Version VA20)Siemens Healthcare GmbH20170—
+7K142750JiveXVisus Technology Transfer GmbH20156—
+8K260973InferOperate SuiteBeijing Infervision Healthcare Medical Technology Co., Ltd.20260—
+8K261713Synapse PACS (7.6.0)FUJIFILM Healthcare Americas Corporation20260—
+8K254189Synapse 3D Base Tools (V7.2)Fujifilm Corporation20260—
+8K260166Bunkerhill Contrast CACBunkerHill Health20260—
+8K252838MAGNETOM Sola; MAGNETOM Altea; MAGNETOM Sola Fit; MAGNETOM Viato.Mobile; MAGNETOM Vida…Siemens Healthcare GmbH20251—
+8K250662Bunkerhill MACBunkerHill Health20250—
+8K242624Medical Image Post-processing Software (uOmnispace.CT)Shanghai United Imaging Healthcare Co., Ltd.20250—
+8K243229Bunkerhill AVCBunkerHill Health20253—
+8K242188ClearRead CT CACRiverain Technologies, Inc.20240—
+8K233186uOmnispace.MRShanghai United Imaging Healthcare Co., Ltd.20241—
+8K230561Syngo Carbon Space VA30ASiemens Healthcare GmbH20234—
+8K222975Advantis PlatformAdvantis Medical Imaging Single Member P.C.20230—
+8K221501syngo.via View&GOSiemens Healthcare GmbH20222—
+8K214019syngo.CT Extended FunctionalitySiemens Medical Solutions USA, Inc.20221—
+8K213096Al-Rad Companion (Pulmonary)Siemens Medical Solutions USA, Inc.20210—
+8K193283AI-Rad Companion Prostate MRSiemens Medical Solutions USA, Inc.20202—
+8K193294AI-Rad Companion EngineSiemens Medical Solutions USA, Inc.20200—
+8K200132AshvinsMedicalcommunications GmbH202001
+8K192462syngo.MR ApplicationsSiemens Medical Solutions USA, Inc.20201—
+8K182904syngo.MR ApplicationsSiemens Medical Solutions USA, Inc.201914—
+8K162008JiveXVisus Technology Transfer GmbH20164—
+9K263048Syngo Carbon Space (VA4)Siemens Healthineers AG20260—
+9K252571mdprostateMediaire GmbH20260—
+9K260852MAGNETOM Flow.Elite;MAGNETOM Flow.Neo;MAGNETOM Flow.Rise;MAGNETOM Flow.PureSiemens Healthineers AG20260—
+9K253690LungMapsSiemens Healthineers AG20260—
+9K253077uOmnispace.MRShanghai United Imaging Healthcare Co., Ltd.20260—
+9K260167Bunkerhill Contrast AVCBunkerHill Health20260—
+9K253495syngo.MR Applications (VB80)Siemens Healthineers AG20250—
+9K252608AI-Rad Companion Prostate MRSiemens Healthcare GmbH20250—
+9K240294Syngo Carbon Enterprise Access (VA40A)Siemens Healthcare GmbH20240—
+9K232856Syngo Carbon ClinicalsSiemens Healthcare GmbH20231—
+9K231351Chondral QuantSiemens Medical Soultions USA, Inc.20230—
+9K230196syngo.via View&GO VA40ASiemens Healthcare GmbH20231—
+9K221727syngo.CT Extended FunctionalitySiemens Medical Solutions USA, Inc.20220—
+9K193290AI-Rad Companion Brain MRSiemens Medical Solutions USA, Inc.202011—
+9K181964JiveXVisus Health IT GmbH20183—
+10K252634Imagine® Enterprise SuiteSoftlink International Private Limited20260—
+10K251059Syngo Carbon Clinicals (VA41)Siemens Healthineers AG20250—
+10K241211CoLumboSmart Soft Healthcare20242—
+10K220497CoLumboSmart Soft Healthcare AD20226—
+10K213706AI-Rad Companion Brain MRSiemens Healthcare GmbH20223—
+10K200703JiveXVisus Health IT GmbH20202—
+11K254015CoLumbo C-SpineSmart Soft Healthcare AD20260—
+11K250367CoLumboXSmart Soft Healthcare AD20250—