510(k) Report

Devices descending from K013381

470 later devices reach Advanced Lung Analysis-1 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+8K130383Synapse 3D Cardiac ToolsFujifilm Medical System U.S.A., Inc.20135—
+9K263048Syngo Carbon Space (VA4)Siemens Healthineers AG20260—
+9K252571mdprostateMediaire GmbH20260—
+9K260852MAGNETOM Flow.Elite;MAGNETOM Flow.Neo;MAGNETOM Flow.Rise;MAGNETOM Flow.PureSiemens Healthineers AG20260—
+9K260528OncoStudioOncosoft. Inc.,20260—
+9K253690LungMapsSiemens Healthineers AG20260—
+9K253078ART.1-USSeetreat Pty, Ltd.20260—
+9K253077uOmnispace.MRShanghai United Imaging Healthcare Co., Ltd.20260—
+9K260509AutoContour (RADAC V5)Radformation, Inc.20261—
+9K260167Bunkerhill Contrast AVCBunkerHill Health20260—
+9K253486SKIA-Head (Model: SKIA-ST00)Skia, Inc.20260—
+9K251577Laia XRAugmented Reality Software S.L.20260—
+9K253495syngo.MR Applications (VB80)Siemens Healthineers AG20250—
+9K251805syngo.CT Dual EnergySiemens Medical Solutions USA, Inc.20250—
+9K252608AI-Rad Companion Prostate MRSiemens Healthcare GmbH20250—
+9K252539Tempus PixelArterys, Inc.20250—
+9K251528syngo.via MI Workflows; Scenium; syngo MBFSiemens Medical Solutions USA, Inc.20251—
+9K244012Mosaic (V1.0.1)Navier Medical20250—
+9K240094LumiNE US; LumiAugmedit B.V.20240—
+9K240294Syngo Carbon Enterprise Access (VA40A)Siemens Healthcare GmbH20240—
+9K234068ART-Plan (v.2.2.0)Therapanacea Sas20240—
+9K232856Syngo Carbon ClinicalsSiemens Healthcare GmbH20231—
+9K231351Chondral QuantSiemens Medical Soultions USA, Inc.20230—
+9K223774Contour ProtégéAIMim Software, Inc.20233—
+9K230303AccuFFRangio PlusArteryFlow Technology Co., Ltd.20230—
+9K221711AccuICASArteryFlow Technology Co., Ltd.20230—
+9K230196syngo.via View&GO VA40ASiemens Healthcare GmbH20231—
+9K220783syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc.20223—
+9K213504Aquilion ONE (TSX-306A/3) V10.12 with Spectral Imaging System, Vitrea Software Package…Canon Medical Systems Corporation20226—
+9K213787Monaco RTP SystemElekta Solutions AB20222—
+9K200973Synapse 3D Cardiac ToolsFujifilm Corporaton20204—
+9K193290AI-Rad Companion Brain MRSiemens Medical Solutions USA, Inc.202011—
+9K163421syngo.via MI WorkflowsSiemens Medical Solutions USA, Inc.201711—
+10K262452AutoContour (RADAC V6)Radformation, Inc.20260—
+10K254016MI View&GOSiemens Medical Solutions USA, Inc.20260—
+10K252634Imagine® Enterprise SuiteSoftlink International Private Limited20260—
+10K251059Syngo Carbon Clinicals (VA41)Siemens Healthineers AG20250—
+10K241211CoLumboSmart Soft Healthcare20242—
+10K232799syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc.20242—
+10K232835Aquilion ONE (TSX-308A/3) V1.4 with PIQE Reconstruction SystemCanon Medical Systems Corporation20243—
+10K231765Contour ProtégéAIMim Software, Inc.20232—
+10K223233Monaco RTP SystemElekta Solutions AB20231—
+10K223336Vitrea Software Package, VSTP-002ACanon Medical Systems Corporation20231—
+10K220039AutoSegAi Medic, Inc.20221—
+10K220497CoLumboSmart Soft Healthcare AD20226—
+10K220727inHEART MODELSInheart, Sas20221—
+10K213706AI-Rad Companion Brain MRSiemens Healthcare GmbH20223—
+10K173897syngo.via MI WorkflowsSiemens Medical Solutions USA, Inc.201810—
+11K260207Multimodality Simulation Workspace (MM Sim) (v1.0.0)Philips Medical Systems Nederland B.V.20260—
+11K254015CoLumbo C-SpineSmart Soft Healthcare AD20260—
+11K252304syngo.via RT Image Suite VC10Varian Medical Systems, Inc.20260—
+11K252002Monaco RTP System (6.3)Elekta Solutions AB20260—
+11K250367CoLumboXSmart Soft Healthcare AD20250—
+11K242607ScanDiags Ortho L-Spine MR-QScandiags AG20250—
+11K250035Contour ProtégéAI+Mim Software, Inc.20251—
+11K243158TeraRecon Aorta.CT (1.1.0)Terarecon,Inc.20250—
+11K242403Aquilion ONE (TSX-308A/3) V1.5Canon Medical Systems Corporation20242—
+11K240793MSKaiMskai20240—
+11K241108RemedyLogic AI MRI Lumbar Spine ReaderRemedy Logic, Inc.20240—
+11K240705Vitrea Software Package, VSTP-002A V2.0Canon Medical Systems Corporation20240—
+11K231683inHEART ModelsInheart, Sas20240—
+11K232305AI-Rad Companion Brain MRSiemens Medical Solutions U.S.A.20231—
+11K191309syngo.via MI Workflows VB40A, SceniumSiemens Medical Soultions USA, Inc.20199—
+12K253596Aquilion ONE (TSX-308A/TSX-306A) V2.0Canon Medical Systems Corporation20260—
+12K253270Contour ProtégéAI+Mim Software, Inc.20260—
+12K253057AI-Rad Companion Brain MRSiemens Healthcare GmbH20260—
+12K251645Self-Propelled CT Scan Base Kit, CGBA-035A; Alphenix, INFX-8000C/B, INFX-8000C/S, V9.6…Canon Medical Systems Corporation20250—
+12K201202MI View&GOSiemens Medical Solutions USA, Inc.20203—
+13K242300MI View&GOSiemens Medical Solutions USA, Inc.20241—
+13K222172MI View&GOSiemens Medical Solutions USA, Inc.20222—