510(k) Report

Devices descending from K954874

406 later devices reach Spectef Protocol through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+13K233209uOmnispace.CTShanghai United Imaging Healthcare Co., Ltd.20241—
+13K233176uOmnispace.MIShanghai United Imaging Healthcare Co., Ltd.20230—
+13K233634TeleScanBb Imaging20230—
+13K231928EFAI RTSUITE CT HCAP-Segmentation SystemEver Fortune.Ai, Co., Ltd.20231—
+13K230039uOmnispaceShanghai United Imaging Healthcare Co., Ltd.20230—
+13K223834AccuCheckManteia Technologies Co., Ltd.20231—
+13K221305AI-Rad Companion Organs RTSiemens Medical Solutions USA, Inc.20225—
+13K221727syngo.CT Extended FunctionalitySiemens Medical Solutions USA, Inc.20220—
+13K213665Syngo Carbon Space VA20ASiemens Healthcare GmbH20225—
+13K203744Arterys MICAArterys, Inc.20221—
+13K203172MOSAIQ Oncology Information SystemElekta Solutions AB202081
+13K201948AcroDTI VisualizerAcroviz, Inc.20200—
+13K201477syngo.via View&GOSiemens Healthcare GmbH20203—
+13K192601uWS-MRShanghai United Imaging Healthcare Co., Ltd.20202—
+13K200315Ziostation2Ziosoft, Inc.20200—
+13K192065Syngo.Via RT Image SuiteSiemens Medical Solutions USA, Inc.201962
+13K191384RayCare 2.3RaySearch Laboratories AB (PUBL)20192—
+13K183272AI Rad Companion (Engine)Siemens Medical Solutions USA, Inc.20192—
+13K183037Monaco RTP SystemElekta, Inc.201856
+13K180336syngo.MR ApplicationsSiemens Medical Solutions USA, Inc.201821—
+13K173378syngo®.via protoNeo (Version VA20)Siemens Healthcare GmbH20170—
+13K151192syngo.via MI WorkflowsSiemens Medical Solutions USA, Inc.201514—
+13K142647mint LesionMint Medical GmbH201523
+14K260528OncoStudioOncosoft. Inc.,20260—
+14K260509AutoContour (RADAC V5)Radformation, Inc.20261—
+14K251306Seg Pro V3 (RT-300)Ever Fortune.Ai, Co., Ltd.20260—
+14K252838MAGNETOM Sola; MAGNETOM Altea; MAGNETOM Sola Fit; MAGNETOM Viato.Mobile; MAGNETOM Vida…Siemens Healthcare GmbH20251—
+14K250696AccuCheckManteia Technologies Co., Ltd.20250—
+14K252539Tempus PixelArterys, Inc.20250—
+14K242624Medical Image Post-processing Software (uOmnispace.CT)Shanghai United Imaging Healthcare Co., Ltd.20250—
+14K232928DeepContour (V1.0)Wisdom Technologies., Inc.20240—
+14K233186uOmnispace.MRShanghai United Imaging Healthcare Co., Ltd.20241—
+14K232899AI-Rad Companion Organs RTSiemens Medical Solutions U.S.A.20243—
+14K230561Syngo Carbon Space VA30ASiemens Healthcare GmbH20234—
+14K222975Advantis PlatformAdvantis Medical Imaging Single Member P.C.20230—
+14K223229MOSAIQ® OIS (Oncology Information System)Elekta Solutions AB202304
+14K220929ExcelsiorMerit Cro, Inc.20220—
+14K221501syngo.via View&GOSiemens Healthcare GmbH20222—
+14K211760Panther OISProwess, Inc.20210—
+14K210645RayStation 10.1RaySearch Laboratories AB (PUBL)202156
+14K202229AI MetricsAi Metrics, LLC20200—
+14K201444Syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc.20205—
+14K193283AI-Rad Companion Prostate MRSiemens Medical Solutions USA, Inc.20202—
+14K193294AI-Rad Companion EngineSiemens Medical Solutions USA, Inc.20200—
+14K200899Quantib AI NodeQuantib B.V.20200—
+14K200487RayCare 3.1RaySearch Laboratories AB (PUBL)202015
+14K192462syngo.MR ApplicationsSiemens Medical Solutions USA, Inc.20201—
+14K182904syngo.MR ApplicationsSiemens Medical Solutions USA, Inc.201914—
+14K190178Monaco RTP SystemElekta, Inc.201945
+14K160426syngo.via MI WorkflowsSiemens Medical Solutions USA, Inc.201612—
+14K160317syngo.via MI WorkflowsSiemens Medical Solutions USA, Inc.20160—
+15K263048Syngo Carbon Space (VA4)Siemens Healthineers AG20260—
+15K262452AutoContour (RADAC V6)Radformation, Inc.20260—
+15K252571mdprostateMediaire GmbH20260—
+15K260852MAGNETOM Flow.Elite;MAGNETOM Flow.Neo;MAGNETOM Flow.Rise;MAGNETOM Flow.PureSiemens Healthineers AG20260—
+15K253690LungMapsSiemens Healthineers AG20260—
+15K253077uOmnispace.MRShanghai United Imaging Healthcare Co., Ltd.20260—
+15K253495syngo.MR Applications (VB80)Siemens Healthineers AG20250—
+15K252608AI-Rad Companion Prostate MRSiemens Healthcare GmbH20250—
+15K242992RayCare (2024A SP1)RaySearch Laboratories AB (PUBL)202502
+15K242745AI-Rad Companion Organs RTSiemens Healthcare GmbH20252—
+15K240294Syngo Carbon Enterprise Access (VA40A)Siemens Healthcare GmbH20240—
+15K232856Syngo Carbon ClinicalsSiemens Healthcare GmbH20231—
+15K231351Chondral QuantSiemens Medical Soultions USA, Inc.20230—
+15K230196syngo.via View&GO VA40ASiemens Healthcare GmbH20231—
+15K211867RayStation 11.0RaySearch Laboratories AB (PUBL)202148
+15K211379syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc.202142
+15K202789Monaco Rtp SystemElekta Solutions AB20213—
+15K193290AI-Rad Companion Brain MRSiemens Medical Solutions USA, Inc.202011—
+15K163421syngo.via MI WorkflowsSiemens Medical Solutions USA, Inc.201711—
+16K261306AI Contouring (VA10A)Varian Medical Systems20260—
+16K252548AI-Rad Companion Organs RTSiemens Healthcare GmbH20260—
+16K252634Imagine® Enterprise SuiteSoftlink International Private Limited20260—
+16K251059Syngo Carbon Clinicals (VA41)Siemens Healthineers AG20250—
+16K241211CoLumboSmart Soft Healthcare20242—
+16K220783syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc.20223—
+16K220497CoLumboSmart Soft Healthcare AD20226—
+16K213787Monaco RTP SystemElekta Solutions AB20222—
+16K213706AI-Rad Companion Brain MRSiemens Healthcare GmbH20223—
+16K220141RayStation 11BRaySearch Laboratories AB (PUBL)202236
+16K173897syngo.via MI WorkflowsSiemens Medical Solutions USA, Inc.201810—
+17K254015CoLumbo C-SpineSmart Soft Healthcare AD20260—
+17K250367CoLumboXSmart Soft Healthcare AD20250—
+17K242607ScanDiags Ortho L-Spine MR-QScandiags AG20250—
+17K240793MSKaiMskai20240—
+17K241108RemedyLogic AI MRI Lumbar Spine ReaderRemedy Logic, Inc.20240—
+17K232799syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc.20242—
+17K232305AI-Rad Companion Brain MRSiemens Medical Solutions U.S.A.20231—
+17K222312RayStation 12ARaySearch Laboratories AB (PUBL)202326
+17K223233Monaco RTP SystemElekta Solutions AB20231—
+17K191309syngo.via MI Workflows VB40A, SceniumSiemens Medical Soultions USA, Inc.20199—
+18K260207Multimodality Simulation Workspace (MM Sim) (v1.0.0)Philips Medical Systems Nederland B.V.20260—
+18K252304syngo.via RT Image Suite VC10Varian Medical Systems, Inc.20260—
+18K252002Monaco RTP System (6.3)Elekta Solutions AB20260—
+18K253057AI-Rad Companion Brain MRSiemens Healthcare GmbH20260—
+18K240398RayStation 2023B, RayPlan 2023B, RayStation 2024A, RayPlan 2024A, RayStation 2024A SP3…RaySearch Laboratories AB (PUBL)202512
+18K201195syngo.via MI Workflows, syngo MBFSiemens Medical Solutions USA, Inc.20205—
+18K201202MI View&GOSiemens Medical Solutions USA, Inc.20203—
+19K252109RayStation (2024A SP3)RaySearch Laboratories AB (PUBL)20250—
+19K242300MI View&GOSiemens Medical Solutions USA, Inc.20241—