510(k) Report

Devices descending from K041267

331 later devices reach Cardiq Analysis Iii through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K230023ART-PlanTherapanacea Sas20233—
+7K230685AutoContour Model RADAC V3Radformation, Inc.20235—
+7K223336Vitrea Software Package, VSTP-002ACanon Medical Systems Corporation20231—
+7K222361AI-Rad Companion (Musculoskeletal)Siemens Medical Solutions USA, Inc.20220—
+7K221727syngo.CT Extended FunctionalitySiemens Medical Solutions USA, Inc.20220—
+7K220590aPROMISE XExini Diagnostics AB20220—
+7K213944HealthOSTNanoxai, Ltd.20221—
+7K210632Contour ProtegeAIMim Software, Inc.20215—
+7K202679Optional Screen Display for HeartSee Cardiac P.E.T. Processing Software - HeartSee…Mcgovern Medical School20212—
+7K192630uWS-MIShanghai United Imaging Healthcare Co., Ltd.20201—
+7K192437Arterys MICAArterys, Inc.20202—
+7K192277CardIQ FlowGE Medical Systems SCS20200—
+7K192065Syngo.Via RT Image SuiteSiemens Medical Solutions USA, Inc.201962
+7K183170uWS-CTShanghai United Imaging Healthcare Co., Ltd.20194—
+7K191040syngo.via (Version VB40A)Siemens Healthcare GmbH201910—
+7K190232Synapse PACSFujifilm Corporation2019311
+7K183164uWS-MRShanghai United Imaging Healthcare Co., Ltd.20193—
+7K182208syngo.via View&GO (Version VA10A)Siemens Healthcare GmbH20184—
+7K181343HeartSee Cardiac P.E.T. Processing SoftwareBracco Diagnostics, Inc.20180—
+7K173863Ez3D-i /E3Ewoosoft Co., Ltd.20180—
+7K173475Merge PACSMerge Healthcare Incorporated201712
+7K171463ASPIRE Bellus IIFujifilm Medical Systems U.S.A, Inc.20170—
+7K163668SuitestensaEbit Srl20170—
+7K170952syngo.CT View&GOSiemens Medical Solutions USA, Inc.20173—
+7K163294syngo.MR General, syngo.MR Cardiology, syngo.MR NeurologySiemens Medical Solutions USA, Inc.201723—
+7K161685syngo®.via protoNeo (Version VA10A)Siemens Healthcare GmbH20161—
+7K151233MonacoImpac Medical Systems, Inc.201569
+7K151192syngo.via MI WorkflowsSiemens Medical Solutions USA, Inc.201514—
+7K142647mint LesionMint Medical GmbH201523
+8K260167Bunkerhill Contrast AVCBunkerHill Health20260—
+8K252362GBrain MRIGalileo Cds, Inc.20250—
+8K243647Synapse PACS (7.5)FUJIFILM Healthcare Americas Corporation20251—
+8K250443MAGNETOM Avanto Fit; MAGNETOM Skyra Fit; MAGNETOM Sola Fit; MAGNETOM Viato.MobileSiemens Healthcare GmbH20252Class I
+8K243633Brainlab Elements (7.0); Brainlab Elements Image Fusion (5.0); Brainlab Elements Image…Brainlab AG20250—
+8K243632uWS-Angio BasicShanghai United Imaging Healthcare Co., Ltd.20250—
+8K242994OncoStudio (OS-01)Oncosoft. Co., Ltd.20251—
+8K241757syngo.CT Dual EnergySiemens Medical Solutions USA, Inc.20251—
+8K242403Aquilion ONE (TSX-308A/3) V1.5Canon Medical Systems Corporation20242—
+8K242729AutoContour (Model RADAC V4)Radformation, Inc.20242—
+8K240411uAI PortalShanghai United Imaging Intelligence Co., Ltd.20240—
+8K242275syngo.via MI Workflows; Scenium; syngo MBFSiemens Medical Solutions USA, Inc.20242—
+8K240705Vitrea Software Package, VSTP-002A V2.0Canon Medical Systems Corporation20240—
+8K233209uOmnispace.CTShanghai United Imaging Healthcare Co., Ltd.20241—
+8K233080HealthFLDNano-X AI, Ltd.20240—
+8K232479ART-PlanTherapanacea20232—
+8K233176uOmnispace.MIShanghai United Imaging Healthcare Co., Ltd.20230—
+8K230039uOmnispaceShanghai United Imaging Healthcare Co., Ltd.20230—
+8K220929ExcelsiorMerit Cro, Inc.20220—
+8K213665Syngo Carbon Space VA20ASiemens Healthcare GmbH20225—
+8K203744Arterys MICAArterys, Inc.20221—
+8K213976Contour ProtégéAIMim Software, Inc.20224—
+8K202229AI MetricsAi Metrics, LLC20200—
+8K201948AcroDTI VisualizerAcroviz, Inc.20200—
+8K201444Syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc.20205—
+8K201477syngo.via View&GOSiemens Healthcare GmbH20203—
+8K192601uWS-MRShanghai United Imaging Healthcare Co., Ltd.20202—
+8K192508Medsynapse Ris Pacs & Medsynapse VNAMedsynaptic Private, Ltd.20190—
+8K192455Merge PACSMerge Healthcare Incorporated201904
+8K183272AI Rad Companion (Engine)Siemens Medical Solutions USA, Inc.20192—
+8K183037Monaco RTP SystemElekta, Inc.201856
+8K180336syngo.MR ApplicationsSiemens Medical Solutions USA, Inc.201821—
+8K173378syngo®.via protoNeo (Version VA20)Siemens Healthcare GmbH20170—
+8K160426syngo.via MI WorkflowsSiemens Medical Solutions USA, Inc.201612—
+8K160317syngo.via MI WorkflowsSiemens Medical Solutions USA, Inc.20160—
+9K260528OncoStudioOncosoft. Inc.,20260—
+9K261713Synapse PACS (7.6.0)FUJIFILM Healthcare Americas Corporation20260—
+9K253596Aquilion ONE (TSX-308A/TSX-306A) V2.0Canon Medical Systems Corporation20260—
+9K253078ART.1-USSeetreat Pty, Ltd.20260—
+9K260509AutoContour (RADAC V5)Radformation, Inc.20261—
+9K252838MAGNETOM Sola; MAGNETOM Altea; MAGNETOM Sola Fit; MAGNETOM Viato.Mobile; MAGNETOM Vida…Siemens Healthcare GmbH20251—
+9K251805syngo.CT Dual EnergySiemens Medical Solutions USA, Inc.20250—
+9K251645Self-Propelled CT Scan Base Kit, CGBA-035A; Alphenix, INFX-8000C/B, INFX-8000C/S, V9.6…Canon Medical Systems Corporation20250—
+9K252539Tempus PixelArterys, Inc.20250—
+9K251528syngo.via MI Workflows; Scenium; syngo MBFSiemens Medical Solutions USA, Inc.20251—
+9K242624Medical Image Post-processing Software (uOmnispace.CT)Shanghai United Imaging Healthcare Co., Ltd.20250—
+9K234068ART-Plan (v.2.2.0)Therapanacea Sas20240—
+9K233186uOmnispace.MRShanghai United Imaging Healthcare Co., Ltd.20241—
+9K223774Contour ProtégéAIMim Software, Inc.20233—
+9K230561Syngo Carbon Space VA30ASiemens Healthcare GmbH20234—
+9K222975Advantis PlatformAdvantis Medical Imaging Single Member P.C.20230—
+9K221501syngo.via View&GOSiemens Healthcare GmbH20222—
+9K211379syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc.202142
+9K193283AI-Rad Companion Prostate MRSiemens Medical Solutions USA, Inc.20202—
+9K193294AI-Rad Companion EngineSiemens Medical Solutions USA, Inc.20200—
+9K200899Quantib AI NodeQuantib B.V.20200—
+9K192462syngo.MR ApplicationsSiemens Medical Solutions USA, Inc.20201—
+9K182904syngo.MR ApplicationsSiemens Medical Solutions USA, Inc.201914—
+9K190178Monaco RTP SystemElekta, Inc.201945
+9K163421syngo.via MI WorkflowsSiemens Medical Solutions USA, Inc.201711—
+10K263048Syngo Carbon Space (VA4)Siemens Healthineers AG20260—
+10K262452AutoContour (RADAC V6)Radformation, Inc.20260—
+10K252571mdprostateMediaire GmbH20260—
+10K260852MAGNETOM Flow.Elite;MAGNETOM Flow.Neo;MAGNETOM Flow.Rise;MAGNETOM Flow.PureSiemens Healthineers AG20260—
+10K253690LungMapsSiemens Healthineers AG20260—
+10K253077uOmnispace.MRShanghai United Imaging Healthcare Co., Ltd.20260—
+10K254016MI View&GOSiemens Medical Solutions USA, Inc.20260—
+10K253495syngo.MR Applications (VB80)Siemens Healthineers AG20250—
+10K252608AI-Rad Companion Prostate MRSiemens Healthcare GmbH20250—
+10K240294Syngo Carbon Enterprise Access (VA40A)Siemens Healthcare GmbH20240—
+10K232856Syngo Carbon ClinicalsSiemens Healthcare GmbH20231—