510(k) Report

Devices descending from K982855

381 later devices reach Digirad 2020TC Spect Imaging System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+11K233186uOmnispace.MRShanghai United Imaging Healthcare Co., Ltd.20241—
+11K232899AI-Rad Companion Organs RTSiemens Medical Solutions U.S.A.20243—
+11K232835Aquilion ONE (TSX-308A/3) V1.4 with PIQE Reconstruction SystemCanon Medical Systems Corporation20243—
+11K230561Syngo Carbon Space VA30ASiemens Healthcare GmbH20234—
+11K222975Advantis PlatformAdvantis Medical Imaging Single Member P.C.20230—
+11K223229MOSAIQ® OIS (Oncology Information System)Elekta Solutions AB202304
+11K223336Vitrea Software Package, VSTP-002ACanon Medical Systems Corporation20231—
+11K220929ExcelsiorMerit Cro, Inc.20220—
+11K221501syngo.via View&GOSiemens Healthcare GmbH20222—
+11K211760Panther OISProwess, Inc.20210—
+11K210645RayStation 10.1RaySearch Laboratories AB (PUBL)202156
+11K202229AI MetricsAi Metrics, LLC20200—
+11K201444Syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc.20205—
+11K193283AI-Rad Companion Prostate MRSiemens Medical Solutions USA, Inc.20202—
+11K193294AI-Rad Companion EngineSiemens Medical Solutions USA, Inc.20200—
+11K200899Quantib AI NodeQuantib B.V.20200—
+11K200487RayCare 3.1RaySearch Laboratories AB (PUBL)202015
+11K192462syngo.MR ApplicationsSiemens Medical Solutions USA, Inc.20201—
+11K182904syngo.MR ApplicationsSiemens Medical Solutions USA, Inc.201914—
+11K190178Monaco RTP SystemElekta, Inc.201945
+11K160426syngo.via MI WorkflowsSiemens Medical Solutions USA, Inc.201612—
+11K160317syngo.via MI WorkflowsSiemens Medical Solutions USA, Inc.20160—
+12K263048Syngo Carbon Space (VA4)Siemens Healthineers AG20260—
+12K262452AutoContour (RADAC V6)Radformation, Inc.20260—
+12K252571mdprostateMediaire GmbH20260—
+12K260852MAGNETOM Flow.Elite;MAGNETOM Flow.Neo;MAGNETOM Flow.Rise;MAGNETOM Flow.PureSiemens Healthineers AG20260—
+12K253690LungMapsSiemens Healthineers AG20260—
+12K253077uOmnispace.MRShanghai United Imaging Healthcare Co., Ltd.20260—
+12K253495syngo.MR Applications (VB80)Siemens Healthineers AG20250—
+12K252608AI-Rad Companion Prostate MRSiemens Healthcare GmbH20250—
+12K242992RayCare (2024A SP1)RaySearch Laboratories AB (PUBL)202502
+12K242745AI-Rad Companion Organs RTSiemens Healthcare GmbH20252—
+12K242403Aquilion ONE (TSX-308A/3) V1.5Canon Medical Systems Corporation20242—
+12K240705Vitrea Software Package, VSTP-002A V2.0Canon Medical Systems Corporation20240—
+12K240294Syngo Carbon Enterprise Access (VA40A)Siemens Healthcare GmbH20240—
+12K232856Syngo Carbon ClinicalsSiemens Healthcare GmbH20231—
+12K231351Chondral QuantSiemens Medical Soultions USA, Inc.20230—
+12K230196syngo.via View&GO VA40ASiemens Healthcare GmbH20231—
+12K211867RayStation 11.0RaySearch Laboratories AB (PUBL)202148
+12K211379syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc.202142
+12K202789Monaco Rtp SystemElekta Solutions AB20213—
+12K193290AI-Rad Companion Brain MRSiemens Medical Solutions USA, Inc.202011—
+12K163421syngo.via MI WorkflowsSiemens Medical Solutions USA, Inc.201711—
+13K261306AI Contouring (VA10A)Varian Medical Systems20260—
+13K253596Aquilion ONE (TSX-308A/TSX-306A) V2.0Canon Medical Systems Corporation20260—
+13K252548AI-Rad Companion Organs RTSiemens Healthcare GmbH20260—
+13K252634Imagine® Enterprise SuiteSoftlink International Private Limited20260—
+13K251059Syngo Carbon Clinicals (VA41)Siemens Healthineers AG20250—
+13K251645Self-Propelled CT Scan Base Kit, CGBA-035A; Alphenix, INFX-8000C/B, INFX-8000C/S, V9.6…Canon Medical Systems Corporation20250—
+13K241211CoLumboSmart Soft Healthcare20242—
+13K220783syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc.20223—
+13K220497CoLumboSmart Soft Healthcare AD20226—
+13K213787Monaco RTP SystemElekta Solutions AB20222—
+13K213706AI-Rad Companion Brain MRSiemens Healthcare GmbH20223—
+13K220141RayStation 11BRaySearch Laboratories AB (PUBL)202236
+13K173897syngo.via MI WorkflowsSiemens Medical Solutions USA, Inc.201810—
+14K254015CoLumbo C-SpineSmart Soft Healthcare AD20260—
+14K250367CoLumboXSmart Soft Healthcare AD20250—
+14K242607ScanDiags Ortho L-Spine MR-QScandiags AG20250—
+14K240793MSKaiMskai20240—
+14K241108RemedyLogic AI MRI Lumbar Spine ReaderRemedy Logic, Inc.20240—
+14K232799syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc.20242—
+14K232305AI-Rad Companion Brain MRSiemens Medical Solutions U.S.A.20231—
+14K222312RayStation 12ARaySearch Laboratories AB (PUBL)202326
+14K223233Monaco RTP SystemElekta Solutions AB20231—
+14K191309syngo.via MI Workflows VB40A, SceniumSiemens Medical Soultions USA, Inc.20199—
+15K260207Multimodality Simulation Workspace (MM Sim) (v1.0.0)Philips Medical Systems Nederland B.V.20260—
+15K252304syngo.via RT Image Suite VC10Varian Medical Systems, Inc.20260—
+15K252002Monaco RTP System (6.3)Elekta Solutions AB20260—
+15K253057AI-Rad Companion Brain MRSiemens Healthcare GmbH20260—
+15K240398RayStation 2023B, RayPlan 2023B, RayStation 2024A, RayPlan 2024A, RayStation 2024A SP3…RaySearch Laboratories AB (PUBL)202512
+15K201195syngo.via MI Workflows, syngo MBFSiemens Medical Solutions USA, Inc.20205—
+15K201202MI View&GOSiemens Medical Solutions USA, Inc.20203—
+16K252109RayStation (2024A SP3)RaySearch Laboratories AB (PUBL)20250—
+16K242300MI View&GOSiemens Medical Solutions USA, Inc.20241—
+16K222172MI View&GOSiemens Medical Solutions USA, Inc.20222—
+16K211459syngo.via MI WorkFlows, Scenium, syngo MBFSiemens Medical Solutions USA, Inc.20214—
+17K254016MI View&GOSiemens Medical Solutions USA, Inc.20260—
+17K232000syngo.via MI Workflows; Scenium; syngo MBFSiemens Medical Solutions USA, Inc.20233—
+18K242275syngo.via MI Workflows; Scenium; syngo MBFSiemens Medical Solutions USA, Inc.20242—
+19K251528syngo.via MI Workflows; Scenium; syngo MBFSiemens Medical Solutions USA, Inc.20251—