510(k) Report

Devices descending from K885054

393 later devices reach System Seventy Seven through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K101749Syngo Trued SoftwareSiemens Medical Solutions201076—
+7K093621Syngo.Pet&CT OncologySiemens Medical Solutions USA, Inc.201054—
+7K080325IGROKIgrok, LLC20080—
+8K253532TruSPECT Processing StationSpectrum Dynamics Medical, Ltd.20250—
+8K251883MIM – LesionID ProMim Software, Inc.20250—
+8K231662Aid-UIaid20241—
+8K232045MeVis Liver SuiteMeVis Medical Solutions AG20230—
+8K230023ART-PlanTherapanacea Sas20233—
+8K223774Contour ProtégéAIMim Software, Inc.20233—
+8K213370VeriqaPtw-Freiburg Physikalisch-Technische-Werkstaetten202202
+8K212420Brainlab Elements, Brainlab Elements Contouring, Brainlab Elements Fibertracking…Brainlab AG20213—
+8K210916PVmed Contouring SoftwarePerception Vision Medical Technologies Ltd.Co.20210—
+8K211655aPROMISEExini Diagnostics AB20211—
+8K200323AutoContourRadformation, Inc.20207—
+8K201232Limbus ContourLimbus Ai, Inc.20202—
+8K201798myQA iONIba Dosimetry GmbH202011
+8K191610RTappSegana, LLC20191—
+8K191761Mobius3DVarian Medical Systems, Inc.20195—
+8K183271AI-Rad Companion (Pulmonary)Siemens Medical Solutions USA, Inc.20196—
+8K190042Brainlab Elements Image Fusion AngioBrainlab AG20190—
+8K182966PLANET Onco DoseDosisoft20191—
+8K182624MIM - MRT DosimetryMim Software, Inc.201853—
+8K182601Vitrea Software Package, VSTP-001ACanon Medical Systems Corporation20180—
+8K182016Simplicit90YMirada Medical, Ltd.20183—
+8K183013Vitrea Software Package, VSTP-001ACanon Medical Systems Corporation20189—
+8K182484VERITON CT whole body SPECT/CT systemSpectrum Dynamics Medical, Ltd.20183—
+8K181572Workflow BoxMirada Medical, Ltd.201825—
+8K180815MIM - SPECTRA QuantMim Software, Inc.201854—
+8K173597Scenium VE20 SoftwareSiemens Medical Solutions USA, Inc.20180—
+8K173542Arterys Oncology DLArterys, Inc.20185—
+8K171350Collision CheckRadformation, Inc.20174—
+8K171754NovaPACSNovarad Corporation201741
+8K170434Enterprise Imaging XERO Viewer 8.1Agfa Healthcare N.V.201732
+8K163250Longitudinal Brain Imaging (LoBI) applicationPhilips Medical Systems Nederland B.V.20170—
+8K162955Multi-Modality Tumor Tracking (MMTT) applicationPhilips Medical Systems Nederland B.V.20165—
+8K161201ClearRead CTRiverain Technologies, LLC20165—
+8K160108Synapse PACSFujifilm Medical Systems U.S.A, Inc.201684
+8K151380syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc.20159—
+8K143176UltraLinqUltralinq Healthcare Solutions, Inc.20150—
+8K142196Visage Ease ProVisage Imaging GmbH20150—
+8K141536Viewing Client MobileAxon Medical Technologies Corp.20150—
+8K141855ClarityElekta, Ltd.20140—
+8K140960Picture Archiving and Communications SystemHologic, Inc.20143—
+8K133521Aze Phoenix SoftwareAze, Ltd.20140—
+8K133508Resolutionmd MobileCalgary Scientific, Inc.20145—
+8K132045Advantagesim MD with CT Atlas-Based Contouring and RE-Planning OptionsGe Hungary Kft20138—
+8K123920Syngo.ViaSiemens AG Medical Solutions201363—
+8K123230Mosaiq Oncology Information SystemImpac Medical Systems, Inc.2012207
+8K113620Myrian 1.11Intrasense20126—
+8K120363Syngo RT InterfaceSiemens Medical Solutions USA, Inc.20120—
+8K111861Syngo.MR Onco, Syngo.MR 3D Lesion Segmentation, Syngo.MR Onco EngineSiemens Medical Systems USA20120—
+8K113029Syngo Via MI WorkflowsSiemens Medical Solutions USA, Inc.201120—
+9K260597Virtue QAProNova Solutions20260—
+9K260576MeVis AVM ContourMeVis Medical Solutions AG20260—
+9K254075Synapse Lung Nodule AIFujifilm Corporation20260—
+9K252261InferCare RECISTBeijing Infervision Healthcare Medical Technology Co., Ltd.20260—
+9K252547TheraSphere 360™ Y-90 Management PlatformBoston Scientific Corporation202521
+9K252199AGFA HealthCare Enterprise ImagingAgfa Healthcare N.V.20250—
+9K250039HPACSHealthhub20250—
+9K242919V5med Lung AIV5med, Inc.20250—
+9K241765PLANET Onco Dose (3.2)Dosisoft SA20250—
+9K232479ART-PlanTherapanacea20232—
+9K231765Contour ProtégéAIMim Software, Inc.20232—
+9K223106Brainlab Elements Image Fusion, Contouring (4.5);Image Fusion (4.5);Fibertracking…Brainlab AG20231—
+9K230575Limbus ContourLimbus Ai, Inc.20231—
+9K221796Cyware 4H and Cysart 4HAbys Medical20221—
+9K221612ClearRead CTRiverain Technologies, Inc.20220—
+9K220408Aview RT AcsCoreline Soft Co., Ltd.20220—
+9K220598AutoContour Model RADAC V2Radformation, Inc.20226—
+9K220583ClearCheck Model RADCC V2Radformation, Inc.20223—
+9K213713AI-Rad Companion (Pulmonary)Siemens Healthcare GmbH20221—
+9K212915MVision AI SegmentationMVision AI20221—
+9K220590aPROMISE XExini Diagnostics AB20220—
+9K213096Al-Rad Companion (Pulmonary)Siemens Medical Solutions USA, Inc.20210—
+9K210831OnQ NeuroCortechs Labs, Inc.20213—
+9K212887RTappSegana, Inc.20210—
+9K212218Advanced Algorithms for Treatment Management Applications (AATMA)Elekta Solutions AB20210—
+9K203699syngo. CT Extended FunctionalitiesSiemens Medical Solutions USA, Inc.20213—
+9K202928DV. TargetDeepvoxel, Inc.20210—
+9K203235VBrainVysioneer, Inc.20214—
+9K200822BraidBraid.Health20201—
+9K192969Ezra Plexo SoftwareEzra Ai, Inc.20200—
+9K192880InferRead Lung CT.AIBeijing Infervision Technology Co., Ltd.20201—
+9K191928AccuContourXiamen Manteia Technology, Ltd.202030—
+9K192923Vitrea Software PackageCanon Medical Systems Corporation20208—
+9K191216Voxel Dosimetry™ v1.0Hermes Medical Solutions AB20195—
+9K192424Mobius3DVarian Medical Systems, Inc.20194—
+9K190457VERITON CT whole body SPECT/CT systemSpectrum Dynamics Medical, Ltd.20192—
+9K190694Unifi Workspace v1.0.0Hologic, Inc.20192—
+9K190232Synapse PACSFujifilm Corporation2019311
+9K173001uWS-CTShanghai United Imaging Healthcare Co., Ltd.20185—
+9K172999uWS-MRShanghai United Imaging Healthcare Co., Ltd.20184—
+9K182034Arterys MICAArterys, Inc.20183—
+9K172998uWS-MIShanghai United Imaging Healthcare Co., Ltd.20182—
+9K173475Merge PACSMerge Healthcare Incorporated201712
+9K171463ASPIRE Bellus IIFujifilm Medical Systems U.S.A, Inc.20170—
+9K163668SuitestensaEbit Srl20170—
+9K162370syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc.20168—
+9K161130ResolutionMDCalgary Scientific, Inc.20164—
+9K150843syngo®.via (version VB10A)Siemens AG201546—