510(k) Report

Devices descending from K042674

209 later devices reach Colon Car 1.2 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K230039uOmnispaceShanghai United Imaging Healthcare Co., Ltd.20230—
+6K230112CAC SoftwareImbio, Inc.20230—
+6K230223iCAC DeviceBunkerhill, Inc.20236—
+6K213665Syngo Carbon Space VA20ASiemens Healthcare GmbH20225—
+6K203699syngo. CT Extended FunctionalitiesSiemens Medical Solutions USA, Inc.20213—
+6K201948AcroDTI VisualizerAcroviz, Inc.20200—
+6K201477syngo.via View&GOSiemens Healthcare GmbH20203—
+6K192601uWS-MRShanghai United Imaging Healthcare Co., Ltd.20202—
+6K200699HS70A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20200—
+6K192903RS85 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.202021—
+6K192505HS50/HS60 Diagnostics Ultrasound SystemSamsung Medison Co., Ltd.201910—
+6K191055HS40 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20199—
+6K182932RS85 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201924—
+6K183272AI Rad Companion (Engine)Siemens Medical Solutions USA, Inc.20192—
+6K182594E-CUBE i7Alpinion Medical Systems Co., Ltd.20191—
+6K182595HERA W10 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201826—
+6K181277E-CUBE 12Alpinion Medical Systems Co., Ltd.20187—
+6K180409HS40 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201834—
+6K180336syngo.MR ApplicationsSiemens Medical Solutions USA, Inc.201821—
+6K173378syngo®.via protoNeo (Version VA20)Siemens Healthcare GmbH20170—
+7K260973InferOperate SuiteBeijing Infervision Healthcare Medical Technology Co., Ltd.20260—
+7K261713Synapse PACS (7.6.0)FUJIFILM Healthcare Americas Corporation20260—
+7K254189Synapse 3D Base Tools (V7.2)Fujifilm Corporation20260—
+7K260166Bunkerhill Contrast CACBunkerHill Health20260—
+7K252838MAGNETOM Sola; MAGNETOM Altea; MAGNETOM Sola Fit; MAGNETOM Viato.Mobile; MAGNETOM Vida…Siemens Healthcare GmbH20251—
+7K250662Bunkerhill MACBunkerHill Health20250—
+7K242624Medical Image Post-processing Software (uOmnispace.CT)Shanghai United Imaging Healthcare Co., Ltd.20250—
+7K243229Bunkerhill AVCBunkerHill Health20253—
+7K242188ClearRead CT CACRiverain Technologies, Inc.20240—
+7K233186uOmnispace.MRShanghai United Imaging Healthcare Co., Ltd.20241—
+7K223920Vinno G50, Vinno G55, Vinno M50, Vinno E30, Vinno X5, Vinno X6, Vinno X7, Vinno M55…Vinno Technology (Suzhou) Co.,Ltd20230—
+7K230561Syngo Carbon Space VA30ASiemens Healthcare GmbH20234—
+7K222975Advantis PlatformAdvantis Medical Imaging Single Member P.C.20230—
+7K221501syngo.via View&GOSiemens Healthcare GmbH20222—
+7K213523X-CUBE i8, X-CUBE i9Alpinion Medical Systems Co., Ltd.20220—
+7K214019syngo.CT Extended FunctionalitySiemens Medical Solutions USA, Inc.20221—
+7K213096Al-Rad Companion (Pulmonary)Siemens Medical Solutions USA, Inc.20210—
+7K211824HERA W9, HERA W10 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20213—
+7K211945V8 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.202113—
+7K210959RS85 Diagnostic Ultrasound System, RS80 EVO Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20212—
+7K210068HS50 Diagnostic Ultrasound System, HS60 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20210—
+7K193283AI-Rad Companion Prostate MRSiemens Medical Solutions USA, Inc.20202—
+7K200449X-Cube 90Alpinion Medical Systems Co., Ltd.20204—
+7K200450X-Cube 70Alpinion Medical Systems Co., Ltd.20204—
+7K193294AI-Rad Companion EngineSiemens Medical Solutions USA, Inc.20200—
+7K200899Quantib AI NodeQuantib B.V.20200—
+7K200339HS40 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20208—
+7K192462syngo.MR ApplicationsSiemens Medical Solutions USA, Inc.20201—
+7K192319HERA W9 Diagnostic Ultrasound System, HERA W10 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201920—
+7K182904syngo.MR ApplicationsSiemens Medical Solutions USA, Inc.201914—
+7K191115RS85 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201923—
+7K190444HERA I10 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20190—
+7K182632HS30 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20191—
+8K263048Syngo Carbon Space (VA4)Siemens Healthineers AG20260—
+8K252571mdprostateMediaire GmbH20260—
+8K260852MAGNETOM Flow.Elite;MAGNETOM Flow.Neo;MAGNETOM Flow.Rise;MAGNETOM Flow.PureSiemens Healthineers AG20260—
+8K253690LungMapsSiemens Healthineers AG20260—
+8K253077uOmnispace.MRShanghai United Imaging Healthcare Co., Ltd.20260—
+8K260167Bunkerhill Contrast AVCBunkerHill Health20260—
+8K253495syngo.MR Applications (VB80)Siemens Healthineers AG20250—
+8K252608AI-Rad Companion Prostate MRSiemens Healthcare GmbH20250—
+8K240294Syngo Carbon Enterprise Access (VA40A)Siemens Healthcare GmbH20240—
+8K232856Syngo Carbon ClinicalsSiemens Healthcare GmbH20231—
+8K231351Chondral QuantSiemens Medical Soultions USA, Inc.20230—
+8K230196syngo.via View&GO VA40ASiemens Healthcare GmbH20231—
+8K221727syngo.CT Extended FunctionalitySiemens Medical Solutions USA, Inc.20220—
+8K220975V8 Diagnostic Ultrasound System, V7 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.202212—
+8K221117RS85 Diagnostic Ultrasound System, RS80 EVO Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20221—
+8K220043HERA W10 Diagnostic Ultrasound System, HERA W9 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20222—
+8K211300X-CUBE 90Alpinion Medical Systems Co., Ltd.20213—
+8K211299X-CUBE 70Alpinion Medical Systems Co., Ltd.20213—
+8K210713HM70 EVO Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20214—
+8K210426HS40 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20211—
+8K202556HS30 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20200—
+8K193290AI-Rad Companion Brain MRSiemens Medical Solutions USA, Inc.202011—
+8K192030RS80 EVO Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20190—
+9K252634Imagine® Enterprise SuiteSoftlink International Private Limited20260—
+9K251059Syngo Carbon Clinicals (VA41)Siemens Healthineers AG20250—
+9K241211CoLumboSmart Soft Healthcare20242—
+9K240516RS85 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20240—
+9K230084HERA W10 Diagnostic Ultrasound System; HERA W9 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20231—
+9K223387V8 Diagnostic Ultrasound System, V7 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.202311—
+9K221093X-Cube 70, X-Cube 90Alpinion Medical Systems Co., Ltd.20220—
+9K220857X-Cube 50, X-Cube 60Alpinion Medical Systems Co., Ltd.20221—
+9K221599HS40 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20220—
+9K220497CoLumboSmart Soft Healthcare AD20226—
+9K220269HM70 EVO Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20223—
+9K213706AI-Rad Companion Brain MRSiemens Healthcare GmbH20223—
+10K254015CoLumbo C-SpineSmart Soft Healthcare AD20260—
+10K250367CoLumboXSmart Soft Healthcare AD20250—
+10K242607ScanDiags Ortho L-Spine MR-QScandiags AG20250—
+10K240793MSKaiMskai20240—
+10K240680CDM InsightsOxford Brain Diagnostics, Ltd.20240—
+10K242444HERA W10 Diagnostic Ultrasound System; HERA W9 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20240—
+10K241108RemedyLogic AI MRI Lumbar Spine ReaderRemedy Logic, Inc.20240—
+10K233112HM70 EVO Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20232—
+10K232305AI-Rad Companion Brain MRSiemens Medical Solutions U.S.A.20231—
+10K231772V8/H8 Diagnostic Ultrasound System, V7/H7 Diagnostic Ultrasound System, V6/H6 Diagnostic…Samsung Medison Co., Ltd.20238—
+10K223564X-Cube 50, X-Cube 60Alpinion Medical Systems Co., Ltd.20230—
+11K254099EVO Q30 Diagnostic Ultrasound System; EVO Q20 Diagnostic Ultrasound System; EVO Q10…Samsung Medison Co., Ltd.20261—