510(k) Report

Devices descending from K013422

449 later devices reach Cardiq Function through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+8K230685AutoContour Model RADAC V3Radformation, Inc.20235—
+8K222361AI-Rad Companion (Musculoskeletal)Siemens Medical Solutions USA, Inc.20220—
+8K221727syngo.CT Extended FunctionalitySiemens Medical Solutions USA, Inc.20220—
+8K221463ElucidVivo A.3Elucid Bioimaging, Inc.20221—
+8K220590aPROMISE XExini Diagnostics AB20220—
+8K213944HealthOSTNanoxai, Ltd.20221—
+8K210632Contour ProtegeAIMim Software, Inc.20215—
+8K202679Optional Screen Display for HeartSee Cardiac P.E.T. Processing Software - HeartSee…Mcgovern Medical School20212—
+8K192630uWS-MIShanghai United Imaging Healthcare Co., Ltd.20201—
+8K192437Arterys MICAArterys, Inc.20202—
+8K192277CardIQ FlowGE Medical Systems SCS20200—
+8K191530StoneCheckerImaging Biometrics, LLC20191—
+8K192065Syngo.Via RT Image SuiteSiemens Medical Solutions USA, Inc.201962
+8K183170uWS-CTShanghai United Imaging Healthcare Co., Ltd.20194—
+8K191040syngo.via (Version VB40A)Siemens Healthcare GmbH201910—
+8K190764SurgicalARMedivis, Inc.20196—
+8K190232Synapse PACSFujifilm Corporation2019311
+8K183164uWS-MRShanghai United Imaging Healthcare Co., Ltd.20193—
+8K180867AmCAD-UOAmcad Biomed Corporation20180—
+8K182208syngo.via View&GO (Version VA10A)Siemens Healthcare GmbH20184—
+8K181343HeartSee Cardiac P.E.T. Processing SoftwareBracco Diagnostics, Inc.20180—
+8K173475Merge PACSMerge Healthcare Incorporated201712
+8K171463ASPIRE Bellus IIFujifilm Medical Systems U.S.A, Inc.20170—
+8K163668SuitestensaEbit Srl20170—
+8K170952syngo.CT View&GOSiemens Medical Solutions USA, Inc.20173—
+8K163294syngo.MR General, syngo.MR Cardiology, syngo.MR NeurologySiemens Medical Solutions USA, Inc.201723—
+8K160371NovaPACSNovarad Corporation20165—
+8K161685syngo®.via protoNeo (Version VA10A)Siemens Healthcare GmbH20161—
+8K151988Visible Patient SuiteVisible Patient, Sas20154—
+8K151233MonacoImpac Medical Systems, Inc.201569
+8K151192syngo.via MI WorkflowsSiemens Medical Solutions USA, Inc.201514—
+8K142647mint LesionMint Medical GmbH201523
+9K253596Aquilion ONE (TSX-308A/TSX-306A) V2.0Canon Medical Systems Corporation20260—
+9K251645Self-Propelled CT Scan Base Kit, CGBA-035A; Alphenix, INFX-8000C/B, INFX-8000C/S, V9.6…Canon Medical Systems Corporation20250—
+9K252362GBrain MRIGalileo Cds, Inc.20250—
+9K251766TumorSight VizSimBioSys, Inc.20250—
+9K243647Synapse PACS (7.5)FUJIFILM Healthcare Americas Corporation20251—
+9K250443MAGNETOM Avanto Fit; MAGNETOM Skyra Fit; MAGNETOM Sola Fit; MAGNETOM Viato.MobileSiemens Healthcare GmbH20252Class I
+9K244012Mosaic (V1.0.1)Navier Medical20250—
+9K243633Brainlab Elements (7.0); Brainlab Elements Image Fusion (5.0); Brainlab Elements Image…Brainlab AG20250—
+9K243632uWS-Angio BasicShanghai United Imaging Healthcare Co., Ltd.20250—
+9K242994OncoStudio (OS-01)Oncosoft. Co., Ltd.20251—
+9K241757syngo.CT Dual EnergySiemens Medical Solutions USA, Inc.20251—
+9K242729AutoContour (Model RADAC V4)Radformation, Inc.20242—
+9K240411uAI PortalShanghai United Imaging Intelligence Co., Ltd.20240—
+9K242275syngo.via MI Workflows; Scenium; syngo MBFSiemens Medical Solutions USA, Inc.20242—
+9K233209uOmnispace.CTShanghai United Imaging Healthcare Co., Ltd.20241—
+9K233080HealthFLDNano-X AI, Ltd.20240—
+9K232479ART-PlanTherapanacea20232—
+9K233176uOmnispace.MIShanghai United Imaging Healthcare Co., Ltd.20230—
+9K230249IkshanaImmersivetouch20231—
+9K230039uOmnispaceShanghai United Imaging Healthcare Co., Ltd.20230—
+9K221870CarnaLife HoloMedapp S.A.20230—
+9K213215VSI HoloMedicineApoqlar GmbH20222—
+9K220929ExcelsiorMerit Cro, Inc.20220—
+9K213665Syngo Carbon Space VA20ASiemens Healthcare GmbH20225—
+9K203744Arterys MICAArterys, Inc.20221—
+9K213976Contour ProtégéAIMim Software, Inc.20224—
+9K212896Visible Patient SuiteVisible Patient, Sas20213—
+9K202084DeepLook PRECISEDeeplook, Inc.20210—
+9K202229AI MetricsAi Metrics, LLC20200—
+9K201948AcroDTI VisualizerAcroviz, Inc.20200—
+9K201444Syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc.20205—
+9K201477syngo.via View&GOSiemens Healthcare GmbH20203—
+9K192601uWS-MRShanghai United Imaging Healthcare Co., Ltd.20202—
+9K192508Medsynapse Ris Pacs & Medsynapse VNAMedsynaptic Private, Ltd.20190—
+9K192455Merge PACSMerge Healthcare Incorporated201904
+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—
+9K171754NovaPACSNovarad Corporation201741
+9K160426syngo.via MI WorkflowsSiemens Medical Solutions USA, Inc.201612—
+9K160317syngo.via MI WorkflowsSiemens Medical Solutions USA, Inc.20160—
+10K260528OncoStudioOncosoft. Inc.,20260—
+10K261713Synapse PACS (7.6.0)FUJIFILM Healthcare Americas Corporation20260—
+10K253078ART.1-USSeetreat Pty, Ltd.20260—
+10K260509AutoContour (RADAC V5)Radformation, Inc.20261—
+10K253486SKIA-Head (Model: SKIA-ST00)Skia, Inc.20260—
+10K251577Laia XRAugmented Reality Software S.L.20260—
+10K252838MAGNETOM Sola; MAGNETOM Altea; MAGNETOM Sola Fit; MAGNETOM Viato.Mobile; MAGNETOM Vida…Siemens Healthcare GmbH20251—
+10K251805syngo.CT Dual EnergySiemens Medical Solutions USA, Inc.20250—
+10K250237InferOperate SuiteBeijing Infervision Healthcare Medical Technology Co., Ltd.20251—
+10K252539Tempus PixelArterys, Inc.20250—
+10K251528syngo.via MI Workflows; Scenium; syngo MBFSiemens Medical Solutions USA, Inc.20251—
+10K242624Medical Image Post-processing Software (uOmnispace.CT)Shanghai United Imaging Healthcare Co., Ltd.20250—
+10K240094LumiNE US; LumiAugmedit B.V.20240—
+10K233457RUSHutom, Inc.20240—
+10K234068ART-Plan (v.2.2.0)Therapanacea Sas20240—
+10K233186uOmnispace.MRShanghai United Imaging Healthcare Co., Ltd.20241—
+10K231662Aid-UIaid20241—
+10K223774Contour ProtégéAIMim Software, Inc.20233—
+10K230561Syngo Carbon Space VA30ASiemens Healthcare GmbH20234—
+10K222975Advantis PlatformAdvantis Medical Imaging Single Member P.C.20230—
+10K221796Cyware 4H and Cysart 4HAbys Medical20221—
+10K221501syngo.via View&GOSiemens Healthcare GmbH20222—
+10K211379syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc.202142
+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—