510(k) Report

Devices descending from K945512

525 later devices reach HRSW Option for CT Twin Flash through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+11K213665Syngo Carbon Space VA20ASiemens Healthcare GmbH20225—
+11K212376Caas QardiaPie Medical Imaging BV20220—
+11K203744Arterys MICAArterys, Inc.20221—
+11K213976Contour ProtégéAIMim Software, Inc.20224—
+11K213544Tomtec-ArenaTomtec Imaging Systems GmbH20226—
+11K212704Philips EPIQ Diagnostic Ultrasound System, Philips Affiniti Diagnostic Ultrasound SystemPhilips Medical Systems20212—
+11K203312Vitrea Software Package, VSTP-001ACanon Medical Systems Corporation20217—
+11K201948AcroDTI VisualizerAcroviz, Inc.20200—
+11K201477syngo.via View&GOSiemens Healthcare GmbH20203—
+11K192601uWS-MRShanghai United Imaging Healthcare Co., Ltd.20202—
+11K192508Medsynapse Ris Pacs & Medsynapse VNAMedsynaptic Private, Ltd.20190—
+11K192455Merge PACSMerge Healthcare Incorporated201904
+11K192065Syngo.Via RT Image SuiteSiemens Medical Solutions USA, Inc.201962
+11K190178Monaco RTP SystemElekta, Inc.201945
+11K183272AI Rad Companion (Engine)Siemens Medical Solutions USA, Inc.20192—
+11K180336syngo.MR ApplicationsSiemens Medical Solutions USA, Inc.201821—
+11K173378syngo®.via protoNeo (Version VA20)Siemens Healthcare GmbH20170—
+11K151192syngo.via MI WorkflowsSiemens Medical Solutions USA, Inc.201514—
+11K142647mint LesionMint Medical GmbH201523
+12K260973InferOperate SuiteBeijing Infervision Healthcare Medical Technology Co., Ltd.20260—
+12K260528OncoStudioOncosoft. Inc.,20260—
+12K261713Synapse PACS (7.6.0)FUJIFILM Healthcare Americas Corporation20260—
+12K253078ART.1-USSeetreat Pty, Ltd.20260—
+12K260509AutoContour (RADAC V5)Radformation, Inc.20261—
+12K252838MAGNETOM Sola; MAGNETOM Altea; MAGNETOM Sola Fit; MAGNETOM Viato.Mobile; MAGNETOM Vida…Siemens Healthcare GmbH20251—
+12K2503303mensio WorkstationPie Medical Imaging BV202501
+12K252539Tempus PixelArterys, Inc.20250—
+12K242624Medical Image Post-processing Software (uOmnispace.CT)Shanghai United Imaging Healthcare Co., Ltd.20250—
+12K241659Ultrasound Workspace (UWS 6.0)Philips Ultrasound, LLC20250—
+12K242523ACUSON Sequoia Diagnostic Ultrasound System; ACUSON Sequoia Select Diagnostic Ultrasound…Siemens Medical Solutions USA, Inc.20242—
+12K240980EPIQ Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20240—
+12K240850EPIQ Series Diagnostic Ultrasound Systems; Affiniti Series Diagnostic Ultrasound SystemsPhilips Ultrasound, LLC202414—
+12K234068ART-Plan (v.2.2.0)Therapanacea Sas20240—
+12K233186uOmnispace.MRShanghai United Imaging Healthcare Co., Ltd.20241—
+12K230209Sonix HealthOntact Health Co., Ltd.20233—
+12K231190EPIQ Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC202314
+12K223774Contour ProtégéAIMim Software, Inc.20233—
+12K230561Syngo Carbon Space VA30ASiemens Healthcare GmbH20234—
+12K222975Advantis PlatformAdvantis Medical Imaging Single Member P.C.20230—
+12K220929ExcelsiorMerit Cro, Inc.20220—
+12K221501syngo.via View&GOSiemens Healthcare GmbH20222—
+12K213504Aquilion ONE (TSX-306A/3) V10.12 with Spectral Imaging System, Vitrea Software Package…Canon Medical Systems Corporation20226—
+12K202789Monaco Rtp SystemElekta Solutions AB20213—
+12K202229AI MetricsAi Metrics, LLC20200—
+12K201444Syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc.20205—
+12K193283AI-Rad Companion Prostate MRSiemens Medical Solutions USA, Inc.20202—
+12K193294AI-Rad Companion EngineSiemens Medical Solutions USA, Inc.20200—
+12K200899Quantib AI NodeQuantib B.V.20200—
+12K192462syngo.MR ApplicationsSiemens Medical Solutions USA, Inc.20201—
+12K182904syngo.MR ApplicationsSiemens Medical Solutions USA, Inc.201914—
+12K160426syngo.via MI WorkflowsSiemens Medical Solutions USA, Inc.201612—
+12K160317syngo.via MI WorkflowsSiemens Medical Solutions USA, Inc.20160—
+13K263048Syngo Carbon Space (VA4)Siemens Healthineers AG20260—
+13K262452AutoContour (RADAC V6)Radformation, Inc.20260—
+13K252571mdprostateMediaire GmbH20260—
+13K260852MAGNETOM Flow.Elite;MAGNETOM Flow.Neo;MAGNETOM Flow.Rise;MAGNETOM Flow.PureSiemens Healthineers AG20260—
+13K253690LungMapsSiemens Healthineers AG20260—
+13K253077uOmnispace.MRShanghai United Imaging Healthcare Co., Ltd.20260—
+13K253495syngo.MR Applications (VB80)Siemens Healthineers AG20250—
+13K252608AI-Rad Companion Prostate MRSiemens Healthcare GmbH20250—
+13K251481ACUSON Sequoia Diagnostic Ultrasound System; ACUSON Sequoia Select Diagnostic Ultrasound…Siemens Medical Solutions USA, Inc.20251—
+13K251455EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20250—
+13K250886EPIQ Series Diagnostic Ultrasound Systems; Affiniti Series Diagnostic Ultrasound SystemsPhilips Ultrasound, LLC20250—
+13K243793EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20250—
+13K251110EPIQ Series Diagnostic Ultrasound Systems; Affiniti Series Diagnostic Ultrasound SystemsPhilips Ultrasound, LLC20250—
+13K243684BrightHeart View ClassifierBrightheart20251—
+13K243794EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20255—
+13K242020EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20243—
+13K240645Sonix HealthOntact Health Co., Ltd.20240—
+13K240294Syngo Carbon Enterprise Access (VA40A)Siemens Healthcare GmbH20240—
+13K232835Aquilion ONE (TSX-308A/3) V1.4 with PIQE Reconstruction SystemCanon Medical Systems Corporation20243—
+13K232856Syngo Carbon ClinicalsSiemens Healthcare GmbH20231—
+13K233545EPIQ Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC202301
+13K231765Contour ProtégéAIMim Software, Inc.20232—
+13K231351Chondral QuantSiemens Medical Soultions USA, Inc.20230—
+13K230196syngo.via View&GO VA40ASiemens Healthcare GmbH20231—
+13K223336Vitrea Software Package, VSTP-002ACanon Medical Systems Corporation20231—
+13K213787Monaco RTP SystemElekta Solutions AB20222—
+13K211379syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc.202142
+13K193290AI-Rad Companion Brain MRSiemens Medical Solutions USA, Inc.202011—
+13K163421syngo.via MI WorkflowsSiemens Medical Solutions USA, Inc.201711—
+14K260667Alturion Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20261—
+14K260844ACUSON Sequoia Diagnostic Ultrasound System;ACUSON Sequoia Select Diagnostic Ultrasound…Siemens Medical Solutions USA, Inc.20260—
+14K260680EPIQ Series Diagnostic Ultrasound Systems; Affiniti Series Diagnostic Ultrasound SystemsPhilips Ultrasound, LLC202601
+14K253595EPIQ Series Diagnostic Ultrasound System, Affiniti Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20261—
+14K252634Imagine® Enterprise SuiteSoftlink International Private Limited20260—
+14K251059Syngo Carbon Clinicals (VA41)Siemens Healthineers AG20250—
+14K251456BrightHeart View ClassifierBrightheart20250—
+14K250177EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20252—
+14K250035Contour ProtégéAI+Mim Software, Inc.20251—
+14K242403Aquilion ONE (TSX-308A/3) V1.5Canon Medical Systems Corporation20242—
+14K241211CoLumboSmart Soft Healthcare20242—
+14K240705Vitrea Software Package, VSTP-002A V2.0Canon Medical Systems Corporation20240—
+14K223233Monaco RTP SystemElekta Solutions AB20231—
+14K220783syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc.20223—
+14K220497CoLumboSmart Soft Healthcare AD20226—
+14K213706AI-Rad Companion Brain MRSiemens Healthcare GmbH20223—
+14K173897syngo.via MI WorkflowsSiemens Medical Solutions USA, Inc.201810—
+15K262311Alturion Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20260—
+15K253596Aquilion ONE (TSX-308A/TSX-306A) V2.0Canon Medical Systems Corporation20260—