510(k) Report

Devices descending from K071964

287 later devices reach Mim 4.1 (Seastar) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K183272AI Rad Companion (Engine)Siemens Medical Solutions USA, Inc.20192—
+6K183037Monaco RTP SystemElekta, Inc.201856
+6K180336syngo.MR ApplicationsSiemens Medical Solutions USA, Inc.201821—
+6K173378syngo®.via protoNeo (Version VA20)Siemens Healthcare GmbH20170—
+6K151192syngo.via MI WorkflowsSiemens Medical Solutions USA, Inc.201514—
+6K142647mint LesionMint Medical GmbH201523
+7K260528OncoStudioOncosoft. Inc.,20260—
+7K260509AutoContour (RADAC V5)Radformation, Inc.20261—
+7K251306Seg Pro V3 (RT-300)Ever Fortune.Ai, Co., Ltd.20260—
+7K252838MAGNETOM Sola; MAGNETOM Altea; MAGNETOM Sola Fit; MAGNETOM Viato.Mobile; MAGNETOM Vida…Siemens Healthcare GmbH20251—
+7K250696AccuCheckManteia Technologies Co., Ltd.20250—
+7K252539Tempus PixelArterys, Inc.20250—
+7K242624Medical Image Post-processing Software (uOmnispace.CT)Shanghai United Imaging Healthcare Co., Ltd.20250—
+7K250035Contour ProtégéAI+Mim Software, Inc.20251—
+7K232928DeepContour (V1.0)Wisdom Technologies., Inc.20240—
+7K233186uOmnispace.MRShanghai United Imaging Healthcare Co., Ltd.20241—
+7K232899AI-Rad Companion Organs RTSiemens Medical Solutions U.S.A.20243—
+7K232835Aquilion ONE (TSX-308A/3) V1.4 with PIQE Reconstruction SystemCanon Medical Systems Corporation20243—
+7K230561Syngo Carbon Space VA30ASiemens Healthcare GmbH20234—
+7K222975Advantis PlatformAdvantis Medical Imaging Single Member P.C.20230—
+7K223336Vitrea Software Package, VSTP-002ACanon Medical Systems Corporation20231—
+7K220929ExcelsiorMerit Cro, Inc.20220—
+7K221501syngo.via View&GOSiemens Healthcare GmbH20222—
+7K202229AI MetricsAi Metrics, LLC20200—
+7K201444Syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc.20205—
+7K193283AI-Rad Companion Prostate MRSiemens Medical Solutions USA, Inc.20202—
+7K193294AI-Rad Companion EngineSiemens Medical Solutions USA, Inc.20200—
+7K200899Quantib AI NodeQuantib B.V.20200—
+7K192462syngo.MR ApplicationsSiemens Medical Solutions USA, Inc.20201—
+7K182904syngo.MR ApplicationsSiemens Medical Solutions USA, Inc.201914—
+7K190178Monaco RTP SystemElekta, Inc.201945
+7K160426syngo.via MI WorkflowsSiemens Medical Solutions USA, Inc.201612—
+7K160317syngo.via MI WorkflowsSiemens Medical Solutions USA, Inc.20160—
+8K263048Syngo Carbon Space (VA4)Siemens Healthineers AG20260—
+8K262452AutoContour (RADAC V6)Radformation, Inc.20260—
+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—
+8K253270Contour ProtégéAI+Mim Software, Inc.20260—
+8K253495syngo.MR Applications (VB80)Siemens Healthineers AG20250—
+8K252608AI-Rad Companion Prostate MRSiemens Healthcare GmbH20250—
+8K242745AI-Rad Companion Organs RTSiemens Healthcare GmbH20252—
+8K242403Aquilion ONE (TSX-308A/3) V1.5Canon Medical Systems Corporation20242—
+8K240705Vitrea Software Package, VSTP-002A V2.0Canon Medical Systems Corporation20240—
+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—
+8K211379syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc.202142
+8K202789Monaco Rtp SystemElekta Solutions AB20213—
+8K193290AI-Rad Companion Brain MRSiemens Medical Solutions USA, Inc.202011—
+8K163421syngo.via MI WorkflowsSiemens Medical Solutions USA, Inc.201711—
+9K261306AI Contouring (VA10A)Varian Medical Systems20260—
+9K253596Aquilion ONE (TSX-308A/TSX-306A) V2.0Canon Medical Systems Corporation20260—
+9K252548AI-Rad Companion Organs RTSiemens Healthcare GmbH20260—
+9K252634Imagine® Enterprise SuiteSoftlink International Private Limited20260—
+9K251059Syngo Carbon Clinicals (VA41)Siemens Healthineers AG20250—
+9K251645Self-Propelled CT Scan Base Kit, CGBA-035A; Alphenix, INFX-8000C/B, INFX-8000C/S, V9.6…Canon Medical Systems Corporation20250—
+9K241211CoLumboSmart Soft Healthcare20242—
+9K220783syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc.20223—
+9K220497CoLumboSmart Soft Healthcare AD20226—
+9K213787Monaco RTP SystemElekta Solutions AB20222—
+9K213706AI-Rad Companion Brain MRSiemens Healthcare GmbH20223—
+9K173897syngo.via MI WorkflowsSiemens Medical Solutions USA, Inc.201810—
+10K254015CoLumbo C-SpineSmart Soft Healthcare AD20260—
+10K250367CoLumboXSmart Soft Healthcare AD20250—
+10K242607ScanDiags Ortho L-Spine MR-QScandiags AG20250—
+10K240793MSKaiMskai20240—
+10K241108RemedyLogic AI MRI Lumbar Spine ReaderRemedy Logic, Inc.20240—
+10K232799syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc.20242—
+10K232305AI-Rad Companion Brain MRSiemens Medical Solutions U.S.A.20231—
+10K223233Monaco RTP SystemElekta Solutions AB20231—
+10K191309syngo.via MI Workflows VB40A, SceniumSiemens Medical Soultions USA, Inc.20199—
+11K260207Multimodality Simulation Workspace (MM Sim) (v1.0.0)Philips Medical Systems Nederland B.V.20260—
+11K252304syngo.via RT Image Suite VC10Varian Medical Systems, Inc.20260—
+11K252002Monaco RTP System (6.3)Elekta Solutions AB20260—
+11K253057AI-Rad Companion Brain MRSiemens Healthcare GmbH20260—
+11K201195syngo.via MI Workflows, syngo MBFSiemens Medical Solutions USA, Inc.20205—
+11K201202MI View&GOSiemens Medical Solutions USA, Inc.20203—
+12K242300MI View&GOSiemens Medical Solutions USA, Inc.20241—
+12K222172MI View&GOSiemens Medical Solutions USA, Inc.20222—
+12K211459syngo.via MI WorkFlows, Scenium, syngo MBFSiemens Medical Solutions USA, Inc.20214—
+13K254016MI View&GOSiemens Medical Solutions USA, Inc.20260—
+13K232000syngo.via MI Workflows; Scenium; syngo MBFSiemens Medical Solutions USA, Inc.20233—
+14K242275syngo.via MI Workflows; Scenium; syngo MBFSiemens Medical Solutions USA, Inc.20242—
+15K251528syngo.via MI Workflows; Scenium; syngo MBFSiemens Medical Solutions USA, Inc.20251—