510(k) Report

Devices descending from K980914

405 later devices reach Emory Cardiac Tool Box through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+12K233176uOmnispace.MIShanghai United Imaging Healthcare Co., Ltd.20230—
+12K233634TeleScanBb Imaging20230—
+12K231928EFAI RTSUITE CT HCAP-Segmentation SystemEver Fortune.Ai, Co., Ltd.20231—
+12K230039uOmnispaceShanghai United Imaging Healthcare Co., Ltd.20230—
+12K223834AccuCheckManteia Technologies Co., Ltd.20231—
+12K221305AI-Rad Companion Organs RTSiemens Medical Solutions USA, Inc.20225—
+12K221727syngo.CT Extended FunctionalitySiemens Medical Solutions USA, Inc.20220—
+12K213665Syngo Carbon Space VA20ASiemens Healthcare GmbH20225—
+12K203744Arterys MICAArterys, Inc.20221—
+12K203172MOSAIQ Oncology Information SystemElekta Solutions AB202081
+12K201948AcroDTI VisualizerAcroviz, Inc.20200—
+12K201477syngo.via View&GOSiemens Healthcare GmbH20203—
+12K192601uWS-MRShanghai United Imaging Healthcare Co., Ltd.20202—
+12K200315Ziostation2Ziosoft, Inc.20200—
+12K192065Syngo.Via RT Image SuiteSiemens Medical Solutions USA, Inc.201962
+12K191384RayCare 2.3RaySearch Laboratories AB (PUBL)20192—
+12K183272AI Rad Companion (Engine)Siemens Medical Solutions USA, Inc.20192—
+12K183037Monaco RTP SystemElekta, Inc.201856
+12K180336syngo.MR ApplicationsSiemens Medical Solutions USA, Inc.201821—
+12K173378syngo®.via protoNeo (Version VA20)Siemens Healthcare GmbH20170—
+12K151192syngo.via MI WorkflowsSiemens Medical Solutions USA, Inc.201514—
+12K142647mint LesionMint Medical GmbH201523
+13K260528OncoStudioOncosoft. Inc.,20260—
+13K260509AutoContour (RADAC V5)Radformation, Inc.20261—
+13K251306Seg Pro V3 (RT-300)Ever Fortune.Ai, Co., Ltd.20260—
+13K252838MAGNETOM Sola; MAGNETOM Altea; MAGNETOM Sola Fit; MAGNETOM Viato.Mobile; MAGNETOM Vida…Siemens Healthcare GmbH20251—
+13K250696AccuCheckManteia Technologies Co., Ltd.20250—
+13K252539Tempus PixelArterys, Inc.20250—
+13K242624Medical Image Post-processing Software (uOmnispace.CT)Shanghai United Imaging Healthcare Co., Ltd.20250—
+13K232928DeepContour (V1.0)Wisdom Technologies., Inc.20240—
+13K233186uOmnispace.MRShanghai United Imaging Healthcare Co., Ltd.20241—
+13K232899AI-Rad Companion Organs RTSiemens Medical Solutions U.S.A.20243—
+13K230561Syngo Carbon Space VA30ASiemens Healthcare GmbH20234—
+13K222975Advantis PlatformAdvantis Medical Imaging Single Member P.C.20230—
+13K223229MOSAIQ® OIS (Oncology Information System)Elekta Solutions AB202304
+13K220929ExcelsiorMerit Cro, Inc.20220—
+13K221501syngo.via View&GOSiemens Healthcare GmbH20222—
+13K211760Panther OISProwess, Inc.20210—
+13K210645RayStation 10.1RaySearch Laboratories AB (PUBL)202156
+13K202229AI MetricsAi Metrics, LLC20200—
+13K201444Syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc.20205—
+13K193283AI-Rad Companion Prostate MRSiemens Medical Solutions USA, Inc.20202—
+13K193294AI-Rad Companion EngineSiemens Medical Solutions USA, Inc.20200—
+13K200899Quantib AI NodeQuantib B.V.20200—
+13K200487RayCare 3.1RaySearch Laboratories AB (PUBL)202015
+13K192462syngo.MR ApplicationsSiemens Medical Solutions USA, Inc.20201—
+13K182904syngo.MR ApplicationsSiemens Medical Solutions USA, Inc.201914—
+13K190178Monaco RTP SystemElekta, Inc.201945
+13K160426syngo.via MI WorkflowsSiemens Medical Solutions USA, Inc.201612—
+13K160317syngo.via MI WorkflowsSiemens Medical Solutions USA, Inc.20160—
+14K263048Syngo Carbon Space (VA4)Siemens Healthineers AG20260—
+14K262452AutoContour (RADAC V6)Radformation, Inc.20260—
+14K252571mdprostateMediaire GmbH20260—
+14K260852MAGNETOM Flow.Elite;MAGNETOM Flow.Neo;MAGNETOM Flow.Rise;MAGNETOM Flow.PureSiemens Healthineers AG20260—
+14K253690LungMapsSiemens Healthineers AG20260—
+14K253077uOmnispace.MRShanghai United Imaging Healthcare Co., Ltd.20260—
+14K253495syngo.MR Applications (VB80)Siemens Healthineers AG20250—
+14K252608AI-Rad Companion Prostate MRSiemens Healthcare GmbH20250—
+14K242992RayCare (2024A SP1)RaySearch Laboratories AB (PUBL)202502
+14K242745AI-Rad Companion Organs RTSiemens Healthcare GmbH20252—
+14K240294Syngo Carbon Enterprise Access (VA40A)Siemens Healthcare GmbH20240—
+14K232856Syngo Carbon ClinicalsSiemens Healthcare GmbH20231—
+14K231351Chondral QuantSiemens Medical Soultions USA, Inc.20230—
+14K230196syngo.via View&GO VA40ASiemens Healthcare GmbH20231—
+14K211867RayStation 11.0RaySearch Laboratories AB (PUBL)202148
+14K211379syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc.202142
+14K202789Monaco Rtp SystemElekta Solutions AB20213—
+14K193290AI-Rad Companion Brain MRSiemens Medical Solutions USA, Inc.202011—
+14K163421syngo.via MI WorkflowsSiemens Medical Solutions USA, Inc.201711—
+15K261306AI Contouring (VA10A)Varian Medical Systems20260—
+15K252548AI-Rad Companion Organs RTSiemens Healthcare GmbH20260—
+15K252634Imagine® Enterprise SuiteSoftlink International Private Limited20260—
+15K251059Syngo Carbon Clinicals (VA41)Siemens Healthineers AG20250—
+15K241211CoLumboSmart Soft Healthcare20242—
+15K220783syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc.20223—
+15K220497CoLumboSmart Soft Healthcare AD20226—
+15K213787Monaco RTP SystemElekta Solutions AB20222—
+15K213706AI-Rad Companion Brain MRSiemens Healthcare GmbH20223—
+15K220141RayStation 11BRaySearch Laboratories AB (PUBL)202236
+15K173897syngo.via MI WorkflowsSiemens Medical Solutions USA, Inc.201810—
+16K254015CoLumbo C-SpineSmart Soft Healthcare AD20260—
+16K250367CoLumboXSmart Soft Healthcare AD20250—
+16K242607ScanDiags Ortho L-Spine MR-QScandiags AG20250—
+16K240793MSKaiMskai20240—
+16K241108RemedyLogic AI MRI Lumbar Spine ReaderRemedy Logic, Inc.20240—
+16K232799syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc.20242—
+16K232305AI-Rad Companion Brain MRSiemens Medical Solutions U.S.A.20231—
+16K222312RayStation 12ARaySearch Laboratories AB (PUBL)202326
+16K223233Monaco RTP SystemElekta Solutions AB20231—
+16K191309syngo.via MI Workflows VB40A, SceniumSiemens Medical Soultions USA, Inc.20199—
+17K260207Multimodality Simulation Workspace (MM Sim) (v1.0.0)Philips Medical Systems Nederland B.V.20260—
+17K252304syngo.via RT Image Suite VC10Varian Medical Systems, Inc.20260—
+17K252002Monaco RTP System (6.3)Elekta Solutions AB20260—
+17K253057AI-Rad Companion Brain MRSiemens Healthcare GmbH20260—
+17K240398RayStation 2023B, RayPlan 2023B, RayStation 2024A, RayPlan 2024A, RayStation 2024A SP3…RaySearch Laboratories AB (PUBL)202512
+17K201195syngo.via MI Workflows, syngo MBFSiemens Medical Solutions USA, Inc.20205—
+17K201202MI View&GOSiemens Medical Solutions USA, Inc.20203—
+18K252109RayStation (2024A SP3)RaySearch Laboratories AB (PUBL)20250—
+18K242300MI View&GOSiemens Medical Solutions USA, Inc.20241—
+18K222172MI View&GOSiemens Medical Solutions USA, Inc.20222—