510(k) Report

Devices descending from K954874

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+9K123082Mobilect ViewerNephosity, Inc.20130—
+9K130393Mirada RTXMirada Medical, Ltd.201336—
+9K123357Onq RTSOncology Systems, Inc.20120—
+9K121663ClarityElekta, Ltd.20121—
+9K122260Aycan MobileAycan Digitalsysteme GmbH20120—
+9K113244Synapse MPR FusionFujifilm Medical System U.S.A., Inc.20119—
+9K112930Mobile MimMim Software, Inc.201199—
+9K111694ASTRACandelis, Inc.20115—
+9K102000ImagysKeosys Sas20103—
+9K102687Mirada RTMirada Medical, Ltd.201037—
+9K101749Syngo Trued SoftwareSiemens Medical Solutions201076—
+9K093621Syngo.Pet&CT OncologySiemens Medical Solutions USA, Inc.201054—
+9K080325IGROKIgrok, LLC20080—
+10K253786syngo.CT Coronary CockpitSiemens Medical Solutions USA, Inc.20260—
+10K251883MIM – LesionID ProMim Software, Inc.20250—
+10K251656Careverse CoronaryDoc (Careverse CoronaryDoc)Careverse Technology Pte., Ltd.20250—
+10K251837Salix Coronary Plaque (V1.0.0)Artrya Limited20250—
+10K242338Cleerly LABS (v2.0)Cleerly, Inc.20252—
+10K231662Aid-UIaid20241—
+10K232045MeVis Liver SuiteMeVis Medical Solutions AG20230—
+10K230023ART-PlanTherapanacea Sas20233—
+10K223774Contour ProtégéAIMim Software, Inc.20233—
+10K220039AutoSegAi Medic, Inc.20221—
+10K213504Aquilion ONE (TSX-306A/3) V10.12 with Spectral Imaging System, Vitrea Software Package…Canon Medical Systems Corporation20226—
+10K220727inHEART MODELSInheart, Sas20221—
+10K213370VeriqaPtw-Freiburg Physikalisch-Technische-Werkstaetten202202
+10K212420Brainlab Elements, Brainlab Elements Contouring, Brainlab Elements Fibertracking…Brainlab AG20213—
+10K210916PVmed Contouring SoftwarePerception Vision Medical Technologies Ltd.Co.20210—
+10K211655aPROMISEExini Diagnostics AB20211—
+10K200323AutoContourRadformation, Inc.20207—
+10K201232Limbus ContourLimbus Ai, Inc.20202—
+10K201798myQA iONIba Dosimetry GmbH202011
+10K191610RTappSegana, LLC20191—
+10K191761Mobius3DVarian Medical Systems, Inc.20195—
+10K183271AI-Rad Companion (Pulmonary)Siemens Medical Solutions USA, Inc.20196—
+10K190042Brainlab Elements Image Fusion AngioBrainlab AG20190—
+10K182966PLANET Onco DoseDosisoft20191—
+10K182624MIM - MRT DosimetryMim Software, Inc.201853—
+10K182016Simplicit90YMirada Medical, Ltd.20183—
+10K181572Workflow BoxMirada Medical, Ltd.201825—
+10K180815MIM - SPECTRA QuantMim Software, Inc.201854—
+10K173597Scenium VE20 SoftwareSiemens Medical Solutions USA, Inc.20180—
+10K173542Arterys Oncology DLArterys, Inc.20185—
+10K171350Collision CheckRadformation, Inc.20174—
+10K171754NovaPACSNovarad Corporation201741
+10K170434Enterprise Imaging XERO Viewer 8.1Agfa Healthcare N.V.201732
+10K163250Longitudinal Brain Imaging (LoBI) applicationPhilips Medical Systems Nederland B.V.20170—
+10K163539Ez3D-i / E3Ewoosoft Co., Ltd.20161—
+10K162955Multi-Modality Tumor Tracking (MMTT) applicationPhilips Medical Systems Nederland B.V.20165—
+10K161201ClearRead CTRiverain Technologies, LLC20165—
+10K160108Synapse PACSFujifilm Medical Systems U.S.A, Inc.201684
+10K151380syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc.20159—
+10K143176UltraLinqUltralinq Healthcare Solutions, Inc.20150—
+10K142196Visage Ease ProVisage Imaging GmbH20150—
+10K141536Viewing Client MobileAxon Medical Technologies Corp.20150—
+10K141855ClarityElekta, Ltd.20140—
+10K140960Picture Archiving and Communications SystemHologic, Inc.20143—
+10K133521Aze Phoenix SoftwareAze, Ltd.20140—
+10K133508Resolutionmd MobileCalgary Scientific, Inc.20145—
+10K132045Advantagesim MD with CT Atlas-Based Contouring and RE-Planning OptionsGe Hungary Kft20138—
+10K123920Syngo.ViaSiemens AG Medical Solutions201363—
+10K123230Mosaiq Oncology Information SystemImpac Medical Systems, Inc.2012207
+10K113620Myrian 1.11Intrasense20126—
+10K120363Syngo RT InterfaceSiemens Medical Solutions USA, Inc.20120—
+10K111861Syngo.MR Onco, Syngo.MR 3D Lesion Segmentation, Syngo.MR Onco EngineSiemens Medical Systems USA20120—
+10K113029Syngo Via MI WorkflowsSiemens Medical Solutions USA, Inc.201120—
+11K260597Virtue QAProNova Solutions20260—
+11K261210Cleerly PlaqueCleerly, Inc.20260—
+11K260588Cleerly LABSCleerly, Inc.20260—
+11K260576MeVis AVM ContourMeVis Medical Solutions AG20260—
+11K254075Synapse Lung Nodule AIFujifilm Corporation20260—
+11K252261InferCare RECISTBeijing Infervision Healthcare Medical Technology Co., Ltd.20260—
+11K252547TheraSphere 360™ Y-90 Management PlatformBoston Scientific Corporation202521
+11K252199AGFA HealthCare Enterprise ImagingAgfa Healthcare N.V.20250—
+11K250039HPACSHealthhub20250—
+11K242919V5med Lung AIV5med, Inc.20250—
+11K241765PLANET Onco Dose (3.2)Dosisoft SA20250—
+11K243158TeraRecon Aorta.CT (1.1.0)Terarecon,Inc.20250—
+11K232835Aquilion ONE (TSX-308A/3) V1.4 with PIQE Reconstruction SystemCanon Medical Systems Corporation20243—
+11K231683inHEART ModelsInheart, Sas20240—
+11K232479ART-PlanTherapanacea20232—
+11K231765Contour ProtégéAIMim Software, Inc.20232—
+11K223106Brainlab Elements Image Fusion, Contouring (4.5);Image Fusion (4.5);Fibertracking…Brainlab AG20231—
+11K230575Limbus ContourLimbus Ai, Inc.20231—
+11K223336Vitrea Software Package, VSTP-002ACanon Medical Systems Corporation20231—
+11K221796Cyware 4H and Cysart 4HAbys Medical20221—
+11K221612ClearRead CTRiverain Technologies, Inc.20220—
+11K220408Aview RT AcsCoreline Soft Co., Ltd.20220—
+11K220598AutoContour Model RADAC V2Radformation, Inc.20226—
+11K220583ClearCheck Model RADCC V2Radformation, Inc.20223—
+11K213713AI-Rad Companion (Pulmonary)Siemens Healthcare GmbH20221—
+11K212915MVision AI SegmentationMVision AI20221—
+11K220590aPROMISE XExini Diagnostics AB20220—
+11K213096Al-Rad Companion (Pulmonary)Siemens Medical Solutions USA, Inc.20210—
+11K210831OnQ NeuroCortechs Labs, Inc.20213—
+11K212887RTappSegana, Inc.20210—
+11K212218Advanced Algorithms for Treatment Management Applications (AATMA)Elekta Solutions AB20210—
+11K203699syngo. CT Extended FunctionalitiesSiemens Medical Solutions USA, Inc.20213—
+11K202928DV. TargetDeepvoxel, Inc.20210—
+11K203235VBrainVysioneer, Inc.20214—