510(k) Report

Devices descending from K043469

218 later devices reach Syngo Inspace 4D through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K242919V5med Lung AIV5med, Inc.20250—
+5K242411Brainomix 360 e-LungBrainomix Limited20250—
+5K240411uAI PortalShanghai United Imaging Intelligence Co., Ltd.20240—
+5K241440HealthCCSngNano-X AI, Ltd.20240—
+5K233209uOmnispace.CTShanghai United Imaging Healthcare Co., Ltd.20241—
+5K233753AI-Rad Companion (Pulmonary)Siemens Healthcare GmbH20240—
+5K233080HealthFLDNano-X AI, Ltd.20240—
+5K233176uOmnispace.MIShanghai United Imaging Healthcare Co., Ltd.20230—
+5K231631BriefCase-QuantificationAidoc Medical, Ltd.20230—
+5K230039uOmnispaceShanghai United Imaging Healthcare Co., Ltd.20230—
+5K230112CAC SoftwareImbio, Inc.20230—
+5K230223iCAC DeviceBunkerhill, Inc.20236—
+5K221612ClearRead CTRiverain Technologies, Inc.20220—
+5K213665Syngo Carbon Space VA20ASiemens Healthcare GmbH20225—
+5K214019syngo.CT Extended FunctionalitySiemens Medical Solutions USA, Inc.20221—
+5K212896Visible Patient SuiteVisible Patient, Sas20213—
+5K201948AcroDTI VisualizerAcroviz, Inc.20200—
+5K200714AVIEWCoreline Soft Co., Ltd.20205—
+5K192880InferRead Lung CT.AIBeijing Infervision Technology Co., Ltd.20201—
+5K201477syngo.via View&GOSiemens Healthcare GmbH20203—
+5K192601uWS-MRShanghai United Imaging Healthcare Co., Ltd.20202—
+5K200315Ziostation2Ziosoft, Inc.20200—
+5K191468syngo.CT Dual EnergySiemens Medical Solutions USA, Inc.20194—
+5K183272AI Rad Companion (Engine)Siemens Medical Solutions USA, Inc.20192—
+5K182601Vitrea Software Package, VSTP-001ACanon Medical Systems Corporation20180—
+5K180336syngo.MR ApplicationsSiemens Medical Solutions USA, Inc.201821—
+5K173378syngo®.via protoNeo (Version VA20)Siemens Healthcare GmbH20170—
+5K163289syngo. CT Single Source Dual Energy (twin beam)Siemens Medical Solutions USA, Inc., Ultrasound DI20175—
+5K161157Vitrea CT Dual Energy Image ViewVital Images, Inc.20160—
+5K162370syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc.20168—
+5K160334Advanced Medical Imaging Software Suite (KSWVWR)Keosys Sas20162—
+5K153220syngo.CT Single Source Dual Energy (Twin Beam)Siemens Medical Solutions USA, Inc.20166—
+5K150745syngo.CT Single Source Dual EnergySiemens Medical Solutions USA, Inc.201511—
+5K123577Syngo.Via MI WorkflowsSiemens Medical Solutions USA, Inc.201319—
+6K260166Bunkerhill Contrast CACBunkerHill Health20260—
+6K252838MAGNETOM Sola; MAGNETOM Altea; MAGNETOM Sola Fit; MAGNETOM Viato.Mobile; MAGNETOM Vida…Siemens Healthcare GmbH20251—
+6K250662Bunkerhill MACBunkerHill Health20250—
+6K250237InferOperate SuiteBeijing Infervision Healthcare Medical Technology Co., Ltd.20251—
+6K240554InferRead Lung CT.AIInfervision Medical Technology Co., Ltd.20250—
+6K242624Medical Image Post-processing Software (uOmnispace.CT)Shanghai United Imaging Healthcare Co., Ltd.20250—
+6K243229Bunkerhill AVCBunkerHill Health20253—
+6K242188ClearRead CT CACRiverain Technologies, Inc.20240—
+6K233457RUSHutom, Inc.20240—
+6K233186uOmnispace.MRShanghai United Imaging Healthcare Co., Ltd.20241—
+6K230561Syngo Carbon Space VA30ASiemens Healthcare GmbH20234—
+6K222975Advantis PlatformAdvantis Medical Imaging Single Member P.C.20230—
+6K214036AVIEWCoreline Soft Co., Ltd.20224—
+6K221501syngo.via View&GOSiemens Healthcare GmbH20222—
+6K221727syngo.CT Extended FunctionalitySiemens Medical Solutions USA, Inc.20220—
+6K212889Syngo.CT Dual EnergySiemens Medical Solutions USA, Inc.20223—
+6K211655aPROMISEExini Diagnostics AB20211—
+6K193283AI-Rad Companion Prostate MRSiemens Medical Solutions USA, Inc.20202—
+6K193294AI-Rad Companion EngineSiemens Medical Solutions USA, Inc.20200—
+6K200899Quantib AI NodeQuantib B.V.20200—
+6K192462syngo.MR ApplicationsSiemens Medical Solutions USA, Inc.20201—
+6K182904syngo.MR ApplicationsSiemens Medical Solutions USA, Inc.201914—
+6K173635syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc.20187—
+6K133644Syngo.Via MI WorkflowsSiemens Medical Solutions USA, Inc.201418—
+7K263048Syngo Carbon Space (VA4)Siemens Healthineers AG20260—
+7K252571mdprostateMediaire GmbH20260—
+7K260852MAGNETOM Flow.Elite;MAGNETOM Flow.Neo;MAGNETOM Flow.Rise;MAGNETOM Flow.PureSiemens Healthineers AG20260—
+7K260973InferOperate SuiteBeijing Infervision Healthcare Medical Technology Co., Ltd.20260—
+7K253690LungMapsSiemens Healthineers AG20260—
+7K253077uOmnispace.MRShanghai United Imaging Healthcare Co., Ltd.20260—
+7K260167Bunkerhill Contrast AVCBunkerHill Health20260—
+7K253495syngo.MR Applications (VB80)Siemens Healthineers AG20250—
+7K252608AI-Rad Companion Prostate MRSiemens Healthcare GmbH20250—
+7K243689AVIEWCoreline Soft Co., Ltd.20250—
+7K240294Syngo Carbon Enterprise Access (VA40A)Siemens Healthcare GmbH20240—
+7K233211Aview CacCoreline Soft Co., Ltd.20242—
+7K232856Syngo Carbon ClinicalsSiemens Healthcare GmbH20231—
+7K232155syngo.CT Dual EnergySiemens Medical Solutions USA, Inc.20232—
+7K231351Chondral QuantSiemens Medical Soultions USA, Inc.20230—
+7K230196syngo.via View&GO VA40ASiemens Healthcare GmbH20231—
+7K220590aPROMISE XExini Diagnostics AB20220—
+7K193290AI-Rad Companion Brain MRSiemens Medical Solutions USA, Inc.202011—
+7K192065Syngo.Via RT Image SuiteSiemens Medical Solutions USA, Inc.201962
+7K151192syngo.via MI WorkflowsSiemens Medical Solutions USA, Inc.201514—
+7K142647mint LesionMint Medical GmbH201523
+8K252634Imagine® Enterprise SuiteSoftlink International Private Limited20260—
+8K251059Syngo Carbon Clinicals (VA41)Siemens Healthineers AG20250—
+8K250288TeraRecon Cardiovascular.Calcification.CTTerarecon,Inc.20250—
+8K243696Aview CacCoreline Soft Co., Ltd.20250—
+8K241757syngo.CT Dual EnergySiemens Medical Solutions USA, Inc.20251—
+8K241211CoLumboSmart Soft Healthcare20242—
+8K220929ExcelsiorMerit Cro, Inc.20220—
+8K220497CoLumboSmart Soft Healthcare AD20226—
+8K213706AI-Rad Companion Brain MRSiemens Healthcare GmbH20223—
+8K202229AI MetricsAi Metrics, LLC20200—
+8K201444Syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc.20205—
+8K160426syngo.via MI WorkflowsSiemens Medical Solutions USA, Inc.201612—
+8K160317syngo.via MI WorkflowsSiemens Medical Solutions USA, Inc.20160—
+9K254015CoLumbo C-SpineSmart Soft Healthcare AD20260—
+9K251805syngo.CT Dual EnergySiemens Medical Solutions USA, Inc.20250—
+9K250367CoLumboXSmart Soft Healthcare AD20250—
+9K242607ScanDiags Ortho L-Spine MR-QScandiags AG20250—
+9K240793MSKaiMskai20240—
+9K240680CDM InsightsOxford Brain Diagnostics, Ltd.20240—
+9K241108RemedyLogic AI MRI Lumbar Spine ReaderRemedy Logic, Inc.20240—
+9K232305AI-Rad Companion Brain MRSiemens Medical Solutions U.S.A.20231—