510(k) Report

Devices descending from K974367

355 later devices reach Advantx LCN, Advantx LCLP through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+8K243769QFR (3.0)Qfr Solutions BV20250—
+8K242919V5med Lung AIV5med, Inc.20250—
+8K242411Brainomix 360 e-LungBrainomix Limited20250—
+8K240411uAI PortalShanghai United Imaging Intelligence Co., Ltd.20240—
+8K233209uOmnispace.CTShanghai United Imaging Healthcare Co., Ltd.20241—
+8K233753AI-Rad Companion (Pulmonary)Siemens Healthcare GmbH20240—
+8K233080HealthFLDNano-X AI, Ltd.20240—
+8K233176uOmnispace.MIShanghai United Imaging Healthcare Co., Ltd.20230—
+8K230039uOmnispaceShanghai United Imaging Healthcare Co., Ltd.20230—
+8K221612ClearRead CTRiverain Technologies, Inc.20220—
+8K222070EndoNautTherenva Sas20221—
+8K213665Syngo Carbon Space VA20ASiemens Healthcare GmbH20225—
+8K214019syngo.CT Extended FunctionalitySiemens Medical Solutions USA, Inc.20221—
+8K212896Visible Patient SuiteVisible Patient, Sas20213—
+8K210093AccuFFRangioArteryFlow Technology Co., Ltd.20212—
+8K201948AcroDTI VisualizerAcroviz, Inc.20200—
+8K200714AVIEWCoreline Soft Co., Ltd.20205—
+8K192880InferRead Lung CT.AIBeijing Infervision Technology Co., Ltd.20201—
+8K201477syngo.via View&GOSiemens Healthcare GmbH20203—
+8K192601uWS-MRShanghai United Imaging Healthcare Co., Ltd.20202—
+8K200315Ziostation2Ziosoft, Inc.20200—
+8K200304EPIQ Diagnostic Ultrasound SystemPhilips Ultrasound, Inc.2020243
+8K191468syngo.CT Dual EnergySiemens Medical Solutions USA, Inc.20194—
+8K183272AI Rad Companion (Engine)Siemens Medical Solutions USA, Inc.20192—
+8K182857EPIQ Diagnostic Ultrasound System, EPIQ 5 Diagnostic Ultrasound System, EPIQ 7…Philips Ultrasound, Inc.20181923
+8K180336syngo.MR ApplicationsSiemens Medical Solutions USA, Inc.201821—
+8K173378syngo®.via protoNeo (Version VA20)Siemens Healthcare GmbH20170—
+8K163289syngo. CT Single Source Dual Energy (twin beam)Siemens Medical Solutions USA, Inc., Ultrasound DI20175—
+8K161157Vitrea CT Dual Energy Image ViewVital Images, Inc.20160—
+8K162370syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc.20168—
+8K162614Infinix, INFX-8000V, V6.35Toshibamedical Systems Corporation20167—
+8K160334Advanced Medical Imaging Software Suite (KSWVWR)Keosys Sas20162—
+8K153220syngo.CT Single Source Dual Energy (Twin Beam)Siemens Medical Solutions USA, Inc.20166—
+8K150745syngo.CT Single Source Dual EnergySiemens Medical Solutions USA, Inc.201511—
+8K150967XIDF-AWS801, Angio Workstation, V6.10Toshibamedical Systems Corporation201551
+8K123577Syngo.Via MI WorkflowsSiemens Medical Solutions USA, Inc.201319—
+9K252838MAGNETOM Sola; MAGNETOM Altea; MAGNETOM Sola Fit; MAGNETOM Viato.Mobile; MAGNETOM Vida…Siemens Healthcare GmbH20251—
+9K250237InferOperate SuiteBeijing Infervision Healthcare Medical Technology Co., Ltd.20251—
+9K243432Vascular Navigation PAD 2.0; Navigation Software Vascular PADBrainlab AG20250—
+9K240554InferRead Lung CT.AIInfervision Medical Technology Co., Ltd.20250—
+9K242624Medical Image Post-processing Software (uOmnispace.CT)Shanghai United Imaging Healthcare Co., Ltd.20250—
+9K233457RUSHutom, Inc.20240—
+9K233186uOmnispace.MRShanghai United Imaging Healthcare Co., Ltd.20241—
+9K230561Syngo Carbon Space VA30ASiemens Healthcare GmbH20234—
+9K230303AccuFFRangio PlusArteryFlow Technology Co., Ltd.20230—
+9K222975Advantis PlatformAdvantis Medical Imaging Single Member P.C.20230—
+9K221711AccuICASArteryFlow Technology Co., Ltd.20230—
+9K214036AVIEWCoreline Soft Co., Ltd.20224—
+9K221501syngo.via View&GOSiemens Healthcare GmbH20222—
+9K2226485000 Compact Series Ultrasound Systems (Ultrasound System 5500 G, Ultrasound System 5500…Philips Ultrasound, LLC202212
+9K221727syngo.CT Extended FunctionalitySiemens Medical Solutions USA, Inc.20220—
+9K212889Syngo.CT Dual EnergySiemens Medical Solutions USA, Inc.20223—
+9K211655aPROMISEExini Diagnostics AB20211—
+9K202216EPIQ Series Diagnostic Ultrasound SystemsPhilips Ultrasound, Inc.2020218
+9K193283AI-Rad Companion Prostate MRSiemens Medical Solutions USA, Inc.20202—
+9K193294AI-Rad Companion EngineSiemens Medical Solutions USA, Inc.20200—
+9K200899Quantib AI NodeQuantib B.V.20200—
+9K201012EPIQ Diagnostic Ultrasound System Series, Affiniti Diagnostic Ultrasound System Series…Philips Ultrasound, Inc.2020185
+9K192462syngo.MR ApplicationsSiemens Medical Solutions USA, Inc.20201—
+9K182904syngo.MR ApplicationsSiemens Medical Solutions USA, Inc.201914—
+9K173635syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc.20187—
+9K172863Infinix-i, INFX-8000V, V7.0Toshibamedical Systems Corporation20175—
+9K170909Infinix INFX-8000V, V6.40Toshiba Medical Systems Coroporation201705
+9K152785XIDF-AWS801, Angio Workstation, V6.20Toshibamedical Systems Corporation201541
+9K133644Syngo.Via MI WorkflowsSiemens Medical Solutions USA, Inc.201418—
+10K263048Syngo Carbon Space (VA4)Siemens Healthineers AG20260—
+10K252571mdprostateMediaire GmbH20260—
+10K260852MAGNETOM Flow.Elite;MAGNETOM Flow.Neo;MAGNETOM Flow.Rise;MAGNETOM Flow.PureSiemens Healthineers AG20260—
+10K260973InferOperate SuiteBeijing Infervision Healthcare Medical Technology Co., Ltd.20260—
+10K253690LungMapsSiemens Healthineers AG20260—
+10K253077uOmnispace.MRShanghai United Imaging Healthcare Co., Ltd.20260—
+10K253495syngo.MR Applications (VB80)Siemens Healthineers AG20250—
+10K252608AI-Rad Companion Prostate MRSiemens Healthcare GmbH20250—
+10K243689AVIEWCoreline Soft Co., Ltd.20250—
+10K242800The 5000 Compact Series Ultrasound SystemsPhilips Ultrasound, LLC20240—
+10K240294Syngo Carbon Enterprise Access (VA40A)Siemens Healthcare GmbH20240—
+10K233211Aview CacCoreline Soft Co., Ltd.20242—
+10K232856Syngo Carbon ClinicalsSiemens Healthcare GmbH20231—
+10K232155syngo.CT Dual EnergySiemens Medical Solutions USA, Inc.20232—
+10K231351Chondral QuantSiemens Medical Soultions USA, Inc.20230—
+10K230196syngo.via View&GO VA40ASiemens Healthcare GmbH20231—
+10K220590aPROMISE XExini Diagnostics AB20220—
+10K212704Philips EPIQ Diagnostic Ultrasound System, Philips Affiniti Diagnostic Ultrasound SystemPhilips Medical Systems20212—
+10K211597EPIQ Series Diagnostic Ultrasound System, Affiniti Series Diagnostic Ultrasound SystemPhilips Medical Systems202117—
+10K193290AI-Rad Companion Brain MRSiemens Medical Solutions USA, Inc.202011—
+10K192065Syngo.Via RT Image SuiteSiemens Medical Solutions USA, Inc.201962
+10K181670Alphenix, INFX-8000V/B, V8.0Canon Medical Systems Corporation201841
+10K172646XIDF-AWS801, Angio Workstation, V7.0Toshibamedical Systems Corporation20173—
+10K151192syngo.via MI WorkflowsSiemens Medical Solutions USA, Inc.201514—
+10K142647mint LesionMint Medical GmbH201523
+11K252634Imagine® Enterprise SuiteSoftlink International Private Limited20260—
+11K251059Syngo Carbon Clinicals (VA41)Siemens Healthineers AG20250—
+11K250288TeraRecon Cardiovascular.Calcification.CTTerarecon,Inc.20250—
+11K243696Aview CacCoreline Soft Co., Ltd.20250—
+11K241757syngo.CT Dual EnergySiemens Medical Solutions USA, Inc.20251—
+11K241211CoLumboSmart Soft Healthcare20242—
+11K233788EPIQ Series Diagnostic Ultrasound System, Affiniti Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC2024161
+11K231190EPIQ Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC202314
+11K220929ExcelsiorMerit Cro, Inc.20220—
+11K220497CoLumboSmart Soft Healthcare AD20226—