510(k) Report

Devices descending from K022919

217 later devices reach Smart Breath Respiratory Compensation Option through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K153289HealthmyneHealthmyne, Inc.20160—
+6K142521Synapse 3D Liver and Kidney AnalysisFujifilm Meidcal Systems U.S.A.,Inc.20145—
+6K133644Syngo.Via MI WorkflowsSiemens Medical Solutions USA, Inc.201418—
+7K252362GBrain MRIGalileo Cds, Inc.20250—
+7K243647Synapse PACS (7.5)FUJIFILM Healthcare Americas Corporation20251—
+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—
+7K242994OncoStudio (OS-01)Oncosoft. Co., Ltd.20251—
+7K242729AutoContour (Model RADAC V4)Radformation, Inc.20242—
+7K240411uAI PortalShanghai United Imaging Intelligence Co., Ltd.20240—
+7K233209uOmnispace.CTShanghai United Imaging Healthcare Co., Ltd.20241—
+7K232479ART-PlanTherapanacea20232—
+7K233176uOmnispace.MIShanghai United Imaging Healthcare Co., Ltd.20230—
+7K230039uOmnispaceShanghai United Imaging Healthcare Co., Ltd.20230—
+7K221727syngo.CT Extended FunctionalitySiemens Medical Solutions USA, Inc.20220—
+7K213665Syngo Carbon Space VA20ASiemens Healthcare GmbH20225—
+7K203744Arterys MICAArterys, Inc.20221—
+7K213976Contour ProtégéAIMim Software, Inc.20224—
+7K203312Vitrea Software Package, VSTP-001ACanon Medical Systems Corporation20217—
+7K201948AcroDTI VisualizerAcroviz, Inc.20200—
+7K201477syngo.via View&GOSiemens Healthcare GmbH20203—
+7K192601uWS-MRShanghai United Imaging Healthcare Co., Ltd.20202—
+7K200315Ziostation2Ziosoft, Inc.20200—
+7K192508Medsynapse Ris Pacs & Medsynapse VNAMedsynaptic Private, Ltd.20190—
+7K192455Merge PACSMerge Healthcare Incorporated201904
+7K192065Syngo.Via RT Image SuiteSiemens Medical Solutions USA, Inc.201962
+7K190178Monaco RTP SystemElekta, Inc.201945
+7K183272AI Rad Companion (Engine)Siemens Medical Solutions USA, Inc.20192—
+7K180336syngo.MR ApplicationsSiemens Medical Solutions USA, Inc.201821—
+7K173378syngo®.via protoNeo (Version VA20)Siemens Healthcare GmbH20170—
+7K151988Visible Patient SuiteVisible Patient, Sas20154—
+7K151192syngo.via MI WorkflowsSiemens Medical Solutions USA, Inc.201514—
+7K142647mint LesionMint Medical GmbH201523
+8K260528OncoStudioOncosoft. Inc.,20260—
+8K261713Synapse PACS (7.6.0)FUJIFILM Healthcare Americas Corporation20260—
+8K253078ART.1-USSeetreat Pty, Ltd.20260—
+8K260509AutoContour (RADAC V5)Radformation, Inc.20261—
+8K252838MAGNETOM Sola; MAGNETOM Altea; MAGNETOM Sola Fit; MAGNETOM Viato.Mobile; MAGNETOM Vida…Siemens Healthcare GmbH20251—
+8K252539Tempus PixelArterys, Inc.20250—
+8K242624Medical Image Post-processing Software (uOmnispace.CT)Shanghai United Imaging Healthcare Co., Ltd.20250—
+8K234068ART-Plan (v.2.2.0)Therapanacea Sas20240—
+8K233186uOmnispace.MRShanghai United Imaging Healthcare Co., Ltd.20241—
+8K223774Contour ProtégéAIMim Software, Inc.20233—
+8K230561Syngo Carbon Space VA30ASiemens Healthcare GmbH20234—
+8K222975Advantis PlatformAdvantis Medical Imaging Single Member P.C.20230—
+8K220929ExcelsiorMerit Cro, Inc.20220—
+8K221501syngo.via View&GOSiemens Healthcare GmbH20222—
+8K213504Aquilion ONE (TSX-306A/3) V10.12 with Spectral Imaging System, Vitrea Software Package…Canon Medical Systems Corporation20226—
+8K212896Visible Patient SuiteVisible Patient, Sas20213—
+8K202789Monaco Rtp SystemElekta Solutions AB20213—
+8K202229AI MetricsAi Metrics, LLC20200—
+8K201444Syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc.20205—
+8K193283AI-Rad Companion Prostate MRSiemens Medical Solutions USA, Inc.20202—
+8K193294AI-Rad Companion EngineSiemens Medical Solutions USA, Inc.20200—
+8K200899Quantib AI NodeQuantib B.V.20200—
+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—
+9K262452AutoContour (RADAC V6)Radformation, Inc.20260—
+9K252571mdprostateMediaire GmbH20260—
+9K260852MAGNETOM Flow.Elite;MAGNETOM Flow.Neo;MAGNETOM Flow.Rise;MAGNETOM Flow.PureSiemens Healthineers AG20260—
+9K253690LungMapsSiemens Healthineers AG20260—
+9K253077uOmnispace.MRShanghai United Imaging Healthcare Co., Ltd.20260—
+9K253495syngo.MR Applications (VB80)Siemens Healthineers AG20250—
+9K250237InferOperate SuiteBeijing Infervision Healthcare Medical Technology Co., Ltd.20251—
+9K252608AI-Rad Companion Prostate MRSiemens Healthcare GmbH20250—
+9K233457RUSHutom, Inc.20240—
+9K240294Syngo Carbon Enterprise Access (VA40A)Siemens Healthcare GmbH20240—
+9K232835Aquilion ONE (TSX-308A/3) V1.4 with PIQE Reconstruction SystemCanon Medical Systems Corporation20243—
+9K232856Syngo Carbon ClinicalsSiemens Healthcare GmbH20231—
+9K231765Contour ProtégéAIMim Software, Inc.20232—
+9K231351Chondral QuantSiemens Medical Soultions USA, Inc.20230—
+9K230196syngo.via View&GO VA40ASiemens Healthcare GmbH20231—
+9K223336Vitrea Software Package, VSTP-002ACanon Medical Systems Corporation20231—
+9K213787Monaco RTP SystemElekta Solutions AB20222—
+9K211379syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc.202142
+9K193290AI-Rad Companion Brain MRSiemens Medical Solutions USA, Inc.202011—
+9K163421syngo.via MI WorkflowsSiemens Medical Solutions USA, Inc.201711—
+10K260973InferOperate SuiteBeijing Infervision Healthcare Medical Technology Co., Ltd.20260—
+10K252634Imagine® Enterprise SuiteSoftlink International Private Limited20260—
+10K251059Syngo Carbon Clinicals (VA41)Siemens Healthineers AG20250—
+10K250035Contour ProtégéAI+Mim Software, Inc.20251—
+10K242403Aquilion ONE (TSX-308A/3) V1.5Canon Medical Systems Corporation20242—
+10K241211CoLumboSmart Soft Healthcare20242—
+10K240705Vitrea Software Package, VSTP-002A V2.0Canon Medical Systems Corporation20240—
+10K223233Monaco RTP SystemElekta Solutions AB20231—
+10K220783syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc.20223—
+10K220497CoLumboSmart Soft Healthcare AD20226—
+10K213706AI-Rad Companion Brain MRSiemens Healthcare GmbH20223—
+10K173897syngo.via MI WorkflowsSiemens Medical Solutions USA, Inc.201810—
+11K253596Aquilion ONE (TSX-308A/TSX-306A) V2.0Canon Medical Systems Corporation20260—
+11K254015CoLumbo C-SpineSmart Soft Healthcare AD20260—
+11K253270Contour ProtégéAI+Mim Software, Inc.20260—
+11K252002Monaco RTP System (6.3)Elekta Solutions AB20260—
+11K251645Self-Propelled CT Scan Base Kit, CGBA-035A; Alphenix, INFX-8000C/B, INFX-8000C/S, V9.6…Canon Medical Systems Corporation20250—
+11K250367CoLumboXSmart Soft Healthcare AD20250—
+11K242607ScanDiags Ortho L-Spine MR-QScandiags AG20250—