510(k) Report

Devices descending from K941223

478 later devices reach Advance Analysis Software through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+10K221711AccuICASArteryFlow Technology Co., Ltd.20230—
+10K230196syngo.via View&GO VA40ASiemens Healthcare GmbH20231—
+10K223336Vitrea Software Package, VSTP-002ACanon Medical Systems Corporation20231—
+10K221463ElucidVivo A.3Elucid Bioimaging, Inc.20221—
+10K211379syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc.202142
+10K202789Monaco Rtp SystemElekta Solutions AB20213—
+10K202412ClearRT Helical kVCT for the Radixact Treatment Delivery SystemAccuray Incorporated20201—
+10K202280Cleerly Labs v2.0Cleerly, Inc.20205—
+10K193290AI-Rad Companion Brain MRSiemens Medical Solutions USA, Inc.202011—
+10K191530StoneCheckerImaging Biometrics, LLC20191—
+10K190764SurgicalARMedivis, Inc.20196—
+10K180867AmCAD-UOAmcad Biomed Corporation20180—
+10K182687Motion Tracking and Compensation Feature for the Radixact Treatment Delivery SystemAccuray Incorporated20180—
+10K182050Linear Accelerator Control Console Software v13.1.010 Update, syngo Radiation Therapy…Siemens Medical Solutions USA, Inc.20180—
+10K171222Vitrea Software Toshiba Package; VSTP-001AToshibamedical Systems Corporation201712—
+10K171086Accuray Precision Treatment Planning SystemAccuray Incorporated20171—
+10K163421syngo.via MI WorkflowsSiemens Medical Solutions USA, Inc.201711—
+10K130383Synapse 3D Cardiac ToolsFujifilm Medical System U.S.A., Inc.20135—
+11K253786syngo.CT Coronary CockpitSiemens Medical Solutions USA, Inc.20260—
+11K252634Imagine® Enterprise SuiteSoftlink International Private Limited20260—
+11K251059Syngo Carbon Clinicals (VA41)Siemens Healthineers AG20250—
+11K251656Careverse CoronaryDoc (Careverse CoronaryDoc)Careverse Technology Pte., Ltd.20250—
+11K251837Salix Coronary Plaque (V1.0.0)Artrya Limited20250—
+11K244012Mosaic (V1.0.1)Navier Medical20250—
+11K242338Cleerly LABS (v2.0)Cleerly, Inc.20252—
+11K243881HeartSee™ Cardiac P.E.T. Processing Software For Myocardial Perfusion and Coronary Flow…Bracco Diagnostics, Inc.20250—
+11K250035Contour ProtégéAI+Mim Software, Inc.20251—
+11K241757syngo.CT Dual EnergySiemens Medical Solutions USA, Inc.20251—
+11K242403Aquilion ONE (TSX-308A/3) V1.5Canon Medical Systems Corporation20242—
+11K241211CoLumboSmart Soft Healthcare20242—
+11K240705Vitrea Software Package, VSTP-002A V2.0Canon Medical Systems Corporation20240—
+11K230249IkshanaImmersivetouch20231—
+11K223159Radixact Treatment Delivery SystemAccuray Incorporated20230—
+11K221870CarnaLife HoloMedapp S.A.20230—
+11K213215VSI HoloMedicineApoqlar GmbH20222—
+11K220783syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc.20223—
+11K220497CoLumboSmart Soft Healthcare AD20226—
+11K213787Monaco RTP SystemElekta Solutions AB20222—
+11K213706AI-Rad Companion Brain MRSiemens Healthcare GmbH20223—
+11K212794Accuray Precision Treatment Planning SystemAccuray Incorporated20210—
+11K202084DeepLook PRECISEDeeplook, Inc.20210—
+11K200973Synapse 3D Cardiac ToolsFujifilm Corporaton20204—
+11K173897syngo.via MI WorkflowsSiemens Medical Solutions USA, Inc.201810—
+12K261210Cleerly PlaqueCleerly, Inc.20260—
+12K260588Cleerly LABSCleerly, Inc.20260—
+12K253596Aquilion ONE (TSX-308A/TSX-306A) V2.0Canon Medical Systems Corporation20260—
+12K254015CoLumbo C-SpineSmart Soft Healthcare AD20260—
+12K253270Contour ProtégéAI+Mim Software, Inc.20260—
+12K253486SKIA-Head (Model: SKIA-ST00)Skia, Inc.20260—
+12K251577Laia XRAugmented Reality Software S.L.20260—
+12K251805syngo.CT Dual EnergySiemens Medical Solutions USA, Inc.20250—
+12K251645Self-Propelled CT Scan Base Kit, CGBA-035A; Alphenix, INFX-8000C/B, INFX-8000C/S, V9.6…Canon Medical Systems Corporation20250—
+12K250367CoLumboXSmart Soft Healthcare AD20250—
+12K242607ScanDiags Ortho L-Spine MR-QScandiags AG20250—
+12K240793MSKaiMskai20240—
+12K241108RemedyLogic AI MRI Lumbar Spine ReaderRemedy Logic, Inc.20240—
+12K240094LumiNE US; LumiAugmedit B.V.20240—
+12K232799syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc.20242—
+12K232305AI-Rad Companion Brain MRSiemens Medical Solutions U.S.A.20231—
+12K223233Monaco RTP SystemElekta Solutions AB20231—
+12K220039AutoSegAi Medic, Inc.20221—
+12K220727inHEART MODELSInheart, Sas20221—
+12K191309syngo.via MI Workflows VB40A, SceniumSiemens Medical Soultions USA, Inc.20199—
+13K260207Multimodality Simulation Workspace (MM Sim) (v1.0.0)Philips Medical Systems Nederland B.V.20260—
+13K252304syngo.via RT Image Suite VC10Varian Medical Systems, Inc.20260—
+13K252002Monaco RTP System (6.3)Elekta Solutions AB20260—
+13K253057AI-Rad Companion Brain MRSiemens Healthcare GmbH20260—
+13K243158TeraRecon Aorta.CT (1.1.0)Terarecon,Inc.20250—
+13K231683inHEART ModelsInheart, Sas20240—
+13K201195syngo.via MI Workflows, syngo MBFSiemens Medical Solutions USA, Inc.20205—
+13K201202MI View&GOSiemens Medical Solutions USA, Inc.20203—
+14K242300MI View&GOSiemens Medical Solutions USA, Inc.20241—
+14K222172MI View&GOSiemens Medical Solutions USA, Inc.20222—
+14K211459syngo.via MI WorkFlows, Scenium, syngo MBFSiemens Medical Solutions USA, Inc.20214—
+15K254016MI View&GOSiemens Medical Solutions USA, Inc.20260—
+15K232000syngo.via MI Workflows; Scenium; syngo MBFSiemens Medical Solutions USA, Inc.20233—
+16K242275syngo.via MI Workflows; Scenium; syngo MBFSiemens Medical Solutions USA, Inc.20242—
+17K251528syngo.via MI Workflows; Scenium; syngo MBFSiemens Medical Solutions USA, Inc.20251—