510(k) Report

Devices descending from K041521

469 later devices reach Volume Viewer Plus through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K190178Monaco RTP SystemElekta, Inc.201945
+6K190232Synapse PACSFujifilm Corporation2019311
+6K183164uWS-MRShanghai United Imaging Healthcare Co., Ltd.20193—
+6K182208syngo.via View&GO (Version VA10A)Siemens Healthcare GmbH20184—
+6K181485EPIQ , EPIQ 5, EPIQ 7, Affiniti 30, Affiniti 50 and Affiniti 70 Diagnostic Ultrasound…Philips Ultrasound, Inc.20182724
+6K173625syngo.CT Clinical ExtensionsSiemens Medical Solutions USA, Inc.20185—
+6K173475Merge PACSMerge Healthcare Incorporated201712
+6K172646XIDF-AWS801, Angio Workstation, V7.0Toshibamedical Systems Corporation20173—
+6K171463ASPIRE Bellus IIFujifilm Medical Systems U.S.A, Inc.20170—
+6K163668SuitestensaEbit Srl20170—
+6K170952syngo.CT View&GOSiemens Medical Solutions USA, Inc.20173—
+6K170221syngo.CT Cardiac PlanningSiemens Healthcare GmbH201711
+6K163294syngo.MR General, syngo.MR Cardiology, syngo.MR NeurologySiemens Medical Solutions USA, Inc.201723—
+6K161685syngo®.via protoNeo (Version VA10A)Siemens Healthcare GmbH20161—
+6K142434Artiste Solution, Sys_VC10C, Phase 2 Update with the Syngo RT Therapist & RT Oncologist…Siemens Medical Solutions USA, Inc.201415
+6K133644Syngo.Via MI WorkflowsSiemens Medical Solutions USA, Inc.201418—
+7K260528OncoStudioOncosoft. Inc.,20260—
+7K253078ART.1-USSeetreat Pty, Ltd.20260—
+7K260509AutoContour (RADAC V5)Radformation, Inc.20261—
+7K253614EchoNavigator R5.0Philips Medical Systems Nederland B.V.20260—
+7K250696AccuCheckManteia Technologies Co., Ltd.20250—
+7K252362GBrain MRIGalileo Cds, Inc.20250—
+7K250443MAGNETOM Avanto Fit; MAGNETOM Skyra Fit; MAGNETOM Sola Fit; MAGNETOM Viato.MobileSiemens Healthcare GmbH20252Class I
+7K243633Brainlab Elements (7.0); Brainlab Elements Image Fusion (5.0); Brainlab Elements Image…Brainlab AG20250—
+7K243632uWS-Angio BasicShanghai United Imaging Healthcare Co., Ltd.20250—
+7K240411uAI PortalShanghai United Imaging Intelligence Co., Ltd.20240—
+7K241302SonoSyncSamsung Medison Co., Ltd.20240—
+7K233209uOmnispace.CTShanghai United Imaging Healthcare Co., Ltd.20241—
+7K234068ART-Plan (v.2.2.0)Therapanacea Sas20240—
+7K233176uOmnispace.MIShanghai United Imaging Healthcare Co., Ltd.20230—
+7K232155syngo.CT Dual EnergySiemens Medical Solutions USA, Inc.20232—
+7K230039uOmnispaceShanghai United Imaging Healthcare Co., Ltd.20230—
+7K223424Spine Auto ViewsGE Medical Systems SCS20230—
+7K230803ADAS 3DAdas3D Medical S.L.20232—
+7K222360AI-Rad Companion (Cardiovascular)Siemens Medical Solutions U.S.A.20230—
+7K223774Contour ProtégéAIMim Software, Inc.20233—
+7K222070EndoNautTherenva Sas20221—
+7K222361AI-Rad Companion (Musculoskeletal)Siemens Medical Solutions USA, Inc.20220—
+7K221727syngo.CT Extended FunctionalitySiemens Medical Solutions USA, Inc.20220—
+7K213665Syngo Carbon Space VA20ASiemens Healthcare GmbH20225—
+7K213944HealthOSTNanoxai, Ltd.20221—
+7K203744Arterys MICAArterys, Inc.20221—
+7K210085HealthCCSngZebra Medical Vision, Ltd.20219—
+7K202789Monaco Rtp SystemElekta Solutions AB20213—
+7K203312Vitrea Software Package, VSTP-001ACanon Medical Systems Corporation20217—
+7K201948AcroDTI VisualizerAcroviz, Inc.20200—
+7K201444Syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc.20205—
+7K201477syngo.via View&GOSiemens Healthcare GmbH20203—
+7K192601uWS-MRShanghai United Imaging Healthcare Co., Ltd.20202—
+7K200515syngo.CT Cardiac PlanningSiemens Medical Soultions USA, Inc.20200—
+7K200304EPIQ Diagnostic Ultrasound SystemPhilips Ultrasound, Inc.2020243
+7K192508Medsynapse Ris Pacs & Medsynapse VNAMedsynaptic Private, Ltd.20190—
+7K192455Merge PACSMerge Healthcare Incorporated201904
+7K183272AI Rad Companion (Engine)Siemens Medical Solutions USA, Inc.20192—
+7K182857EPIQ Diagnostic Ultrasound System, EPIQ 5 Diagnostic Ultrasound System, EPIQ 7…Philips Ultrasound, Inc.20181923
+7K182050Linear Accelerator Control Console Software v13.1.010 Update, syngo Radiation Therapy…Siemens Medical Solutions USA, Inc.20180—
+7K181415XIDF - AWS801, Angio Workstation (Alphenix Workstation), V8.0Canon Medical Systems Corporation20182—
+7K180336syngo.MR ApplicationsSiemens Medical Solutions USA, Inc.201821—
+7K173378syngo®.via protoNeo (Version VA20)Siemens Healthcare GmbH20170—
+7K151192syngo.via MI WorkflowsSiemens Medical Solutions USA, Inc.201514—
+8K262452AutoContour (RADAC V6)Radformation, Inc.20260—
+8K252838MAGNETOM Sola; MAGNETOM Altea; MAGNETOM Sola Fit; MAGNETOM Viato.Mobile; MAGNETOM Vida…Siemens Healthcare GmbH20251—
+8K252539Tempus PixelArterys, Inc.20250—
+8K243432Vascular Navigation PAD 2.0; Navigation Software Vascular PADBrainlab AG20250—
+8K241757syngo.CT Dual EnergySiemens Medical Solutions USA, Inc.20251—
+8K240791ADAS 3DAdas3D Medical S.L.20241—
+8K241440HealthCCSngNano-X AI, Ltd.20240—
+8K233186uOmnispace.MRShanghai United Imaging Healthcare Co., Ltd.20241—
+8K233080HealthFLDNano-X AI, Ltd.20240—
+8K231631BriefCase-QuantificationAidoc Medical, Ltd.20230—
+8K231765Contour ProtégéAIMim Software, Inc.20232—
+8K230112CAC SoftwareImbio, Inc.20230—
+8K230223iCAC DeviceBunkerhill, Inc.20236—
+8K230561Syngo Carbon Space VA30ASiemens Healthcare GmbH20234—
+8K222975Advantis PlatformAdvantis Medical Imaging Single Member P.C.20230—
+8K221501syngo.via View&GOSiemens Healthcare GmbH20222—
+8K220342XIDF-AWS801, Angio Workstation (Alphenix Workstation), V9.3Canon Medical Systems Corporation20221—
+8K2226485000 Compact Series Ultrasound Systems (Ultrasound System 5500 G, Ultrasound System 5500…Philips Ultrasound, LLC202212
+8K213504Aquilion ONE (TSX-306A/3) V10.12 with Spectral Imaging System, Vitrea Software Package…Canon Medical Systems Corporation20226—
+8K213787Monaco RTP SystemElekta Solutions AB20222—
+8K211379syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc.202142
+8K202216EPIQ Series Diagnostic Ultrasound SystemsPhilips Ultrasound, Inc.2020218
+8K193283AI-Rad Companion Prostate MRSiemens Medical Solutions USA, Inc.20202—
+8K193294AI-Rad Companion EngineSiemens Medical Solutions USA, Inc.20200—
+8K201012EPIQ Diagnostic Ultrasound System Series, Affiniti Diagnostic Ultrasound System Series…Philips Ultrasound, Inc.2020185
+8K192462syngo.MR ApplicationsSiemens Medical Solutions USA, Inc.20201—
+8K182904syngo.MR ApplicationsSiemens Medical Solutions USA, Inc.201914—
+8K160426syngo.via MI WorkflowsSiemens Medical Solutions USA, Inc.201612—
+8K160317syngo.via MI WorkflowsSiemens Medical Solutions USA, Inc.20160—
+9K263048Syngo Carbon Space (VA4)Siemens Healthineers AG20260—
+9K252571mdprostateMediaire GmbH20260—
+9K260852MAGNETOM Flow.Elite;MAGNETOM Flow.Neo;MAGNETOM Flow.Rise;MAGNETOM Flow.PureSiemens Healthineers AG20260—
+9K253969ADAS 3DAdas3D Medical S.L.20260—
+9K253690LungMapsSiemens Healthineers AG20260—
+9K253077uOmnispace.MRShanghai United Imaging Healthcare Co., Ltd.20260—
+9K260166Bunkerhill Contrast CACBunkerHill Health20260—
+9K253495syngo.MR Applications (VB80)Siemens Healthineers AG20250—
+9K251805syngo.CT Dual EnergySiemens Medical Solutions USA, Inc.20250—
+9K250662Bunkerhill MACBunkerHill Health20250—
+9K252608AI-Rad Companion Prostate MRSiemens Healthcare GmbH20250—