510(k) Report

Devices descending from K022881

413 later devices reach Cedara I-Softview through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+9K230039uOmnispaceShanghai United Imaging Healthcare Co., Ltd.20230—
+9K230064Mazor X System (Mazor X Stealth Edition)Mazor Robotics, Ltd.202332
+9K221727syngo.CT Extended FunctionalitySiemens Medical Solutions USA, Inc.20220—
+9K213665Syngo Carbon Space VA20ASiemens Healthcare GmbH20225—
+9K203744Arterys MICAArterys, Inc.20221—
+9K213976Contour ProtégéAIMim Software, Inc.20224—
+9K211441Navigated Anterolateral Disc Prep InstrumentsMedtronic Sofamor Danek USA, Inc.20219—
+9K203312Vitrea Software Package, VSTP-001ACanon Medical Systems Corporation20217—
+9K201948AcroDTI VisualizerAcroviz, Inc.20200—
+9K201477syngo.via View&GOSiemens Healthcare GmbH20203—
+9K192601uWS-MRShanghai United Imaging Healthcare Co., Ltd.20202—
+9K200315Ziostation2Ziosoft, Inc.20200—
+9K192508Medsynapse Ris Pacs & Medsynapse VNAMedsynaptic Private, Ltd.20190—
+9K192455Merge PACSMerge Healthcare Incorporated201904
+9K192065Syngo.Via RT Image SuiteSiemens Medical Solutions USA, Inc.201962
+9K183272AI Rad Companion (Engine)Siemens Medical Solutions USA, Inc.20192—
+9K183037Monaco RTP SystemElekta, Inc.201856
+9K180336syngo.MR ApplicationsSiemens Medical Solutions USA, Inc.201821—
+9K173378syngo®.via protoNeo (Version VA20)Siemens Healthcare GmbH20170—
+9K151192syngo.via MI WorkflowsSiemens Medical Solutions USA, Inc.201514—
+9K142647mint LesionMint Medical GmbH201523
+10K260528OncoStudioOncosoft. Inc.,20260—
+10K261713Synapse PACS (7.6.0)FUJIFILM Healthcare Americas Corporation20260—
+10K253078ART.1-USSeetreat Pty, Ltd.20260—
+10K260011Foundation Surgical Navigated Lateral Disc Prep InstrumentsFoundation Surgical Group, Inc.20260—
+10K260509AutoContour (RADAC V5)Radformation, Inc.20261—
+10K252838MAGNETOM Sola; MAGNETOM Altea; MAGNETOM Sola Fit; MAGNETOM Viato.Mobile; MAGNETOM Vida…Siemens Healthcare GmbH20251—
+10K251316Mazor X System / Mazor X Stealth EditionMazor Robotics, Ltd.20251—
+10K252539Tempus PixelArterys, Inc.20250—
+10K242624Medical Image Post-processing Software (uOmnispace.CT)Shanghai United Imaging Healthcare Co., Ltd.20250—
+10K240625CORUS Navigation Access SystemProvidence Medical Technology, Inc.20244—
+10K234068ART-Plan (v.2.2.0)Therapanacea Sas20240—
+10K233186uOmnispace.MRShanghai United Imaging Healthcare Co., Ltd.20241—
+10K232345ATEC Posterior Navigated Disc Prep InstrumentsAlphatec Spine, Inc.20232—
+10K230716Robotic Graft Delivery InstrumentsMedtronic Sofamor Danek, Inc.20230—
+10K223774Contour ProtégéAIMim Software, Inc.20233—
+10K230561Syngo Carbon Space VA30ASiemens Healthcare GmbH20234—
+10K222975Advantis PlatformAdvantis Medical Imaging Single Member P.C.20230—
+10K220929ExcelsiorMerit Cro, Inc.20220—
+10K221501syngo.via View&GOSiemens Healthcare GmbH20222—
+10K213504Aquilion ONE (TSX-306A/3) V10.12 with Spectral Imaging System, Vitrea Software Package…Canon Medical Systems Corporation20226—
+10K202229AI MetricsAi Metrics, LLC20200—
+10K201444Syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc.20205—
+10K193283AI-Rad Companion Prostate MRSiemens Medical Solutions USA, Inc.20202—
+10K193294AI-Rad Companion EngineSiemens Medical Solutions USA, Inc.20200—
+10K200899Quantib AI NodeQuantib B.V.20200—
+10K192462syngo.MR ApplicationsSiemens Medical Solutions USA, Inc.20201—
+10K182904syngo.MR ApplicationsSiemens Medical Solutions USA, Inc.201914—
+10K190178Monaco RTP SystemElekta, Inc.201945
+10K160426syngo.via MI WorkflowsSiemens Medical Solutions USA, Inc.201612—
+10K160317syngo.via MI WorkflowsSiemens Medical Solutions USA, Inc.20160—
+11K263048Syngo Carbon Space (VA4)Siemens Healthineers AG20260—
+11K262452AutoContour (RADAC V6)Radformation, Inc.20260—
+11K252571mdprostateMediaire GmbH20260—
+11K260852MAGNETOM Flow.Elite;MAGNETOM Flow.Neo;MAGNETOM Flow.Rise;MAGNETOM Flow.PureSiemens Healthineers AG20260—
+11K253690LungMapsSiemens Healthineers AG20260—
+11K260329Ion-C Navigation InstrumentsSurGenTec, LLC20261—
+11K253077uOmnispace.MRShanghai United Imaging Healthcare Co., Ltd.20260—
+11K252597Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with…Alphatec Spine, Inc.20261—
+11K253381Stealth AXiS™ Surgical System with Stealth AXiS™ Spine clinical applicationMedtronic Navigation, Inc.20260—
+11K253495syngo.MR Applications (VB80)Siemens Healthineers AG20250—
+11K252608AI-Rad Companion Prostate MRSiemens Healthcare GmbH20250—
+11K251060CORUS™ Navigation System-GXProvidence Medical Technology, Inc.20250—
+11K243659FLASH™ Facet Fusion Instruments, IsoTis® Facet Fusion InstrumentsSeaSpine Orthopedics Corporation20250—
+11K240294Syngo Carbon Enterprise Access (VA40A)Siemens Healthcare GmbH20240—
+11K232835Aquilion ONE (TSX-308A/3) V1.4 with PIQE Reconstruction SystemCanon Medical Systems Corporation20243—
+11K232856Syngo Carbon ClinicalsSiemens Healthcare GmbH20231—
+11K231765Contour ProtégéAIMim Software, Inc.20232—
+11K231351Chondral QuantSiemens Medical Soultions USA, Inc.20230—
+11K230196syngo.via View&GO VA40ASiemens Healthcare GmbH20231—
+11K223336Vitrea Software Package, VSTP-002ACanon Medical Systems Corporation20231—
+11K211379syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc.202142
+11K202789Monaco Rtp SystemElekta Solutions AB20213—
+11K193290AI-Rad Companion Brain MRSiemens Medical Solutions USA, Inc.202011—
+11K163421syngo.via MI WorkflowsSiemens Medical Solutions USA, Inc.201711—
+12K262121Ion-L Navigated InstrumentsSurGenTec, LLC20260—
+12K261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemAlphatec Spine, Inc.20260—
+12K252634Imagine® Enterprise SuiteSoftlink International Private Limited20260—
+12K251059Syngo Carbon Clinicals (VA41)Siemens Healthineers AG20250—
+12K250035Contour ProtégéAI+Mim Software, Inc.20251—
+12K242403Aquilion ONE (TSX-308A/3) V1.5Canon Medical Systems Corporation20242—
+12K241211CoLumboSmart Soft Healthcare20242—
+12K240705Vitrea Software Package, VSTP-002A V2.0Canon Medical Systems Corporation20240—
+12K220783syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc.20223—
+12K220497CoLumboSmart Soft Healthcare AD20226—
+12K213787Monaco RTP SystemElekta Solutions AB20222—
+12K213706AI-Rad Companion Brain MRSiemens Healthcare GmbH20223—
+12K173897syngo.via MI WorkflowsSiemens Medical Solutions USA, Inc.201810—
+13K253596Aquilion ONE (TSX-308A/TSX-306A) V2.0Canon Medical Systems Corporation20260—
+13K254015CoLumbo C-SpineSmart Soft Healthcare AD20260—
+13K253270Contour ProtégéAI+Mim Software, Inc.20260—
+13K251645Self-Propelled CT Scan Base Kit, CGBA-035A; Alphenix, INFX-8000C/B, INFX-8000C/S, V9.6…Canon Medical Systems Corporation20250—
+13K250367CoLumboXSmart Soft Healthcare AD20250—
+13K242607ScanDiags Ortho L-Spine MR-QScandiags AG20250—
+13K240793MSKaiMskai20240—
+13K241108RemedyLogic AI MRI Lumbar Spine ReaderRemedy Logic, Inc.20240—
+13K232799syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc.20242—
+13K232305AI-Rad Companion Brain MRSiemens Medical Solutions U.S.A.20231—
+13K223233Monaco RTP SystemElekta Solutions AB20231—
+13K191309syngo.via MI Workflows VB40A, SceniumSiemens Medical Soultions USA, Inc.20199—