510(k) Report

Devices descending from K042293

147 later devices reach Brilliance CT, Private Practice CV Configuration, CT Scanner through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K130159Qlab Quantification Software Heart ModelPhilips Health Care201392—
+1K1125303DI Including CscoreShina Systems, Ltd.20111—
+1K101311EP Navigator R3Philips Medical Systems North America Co.201041—
+1K092747Philips Comprehensive Cardiac Analysis (Cca) - Plaque Assessment ToolPhilips Medical Systems (Cleveland), Inc.200919—
+1K062650EP Navigator SoftwarePhilips Medical Systems200649—
+1K051351Precedence Spect/CT Imaging SystemAdac Laboratories200501
+2K240786AutoChamberHeartLung Corporation20241—
+2K163622Lung VisionBodyvision Medical, Ltd.20176—
+2K142126EP Navigator Rel. 5.0Philips Medical Systems Nederland B.V.20140—
+2K133385Lungpoint Atv Planning and Navigation SoftwareBroncus Medical, Inc.20140—
+2K132165Qlab Quantification SoftwarePhilips Ultrasound, Inc.2013911
+2K122429Vessel Analysis and Autoplaque for Ors VisualObject Research Systems (Ors), Inc.201216—
+2K1134423DIShina Systems, Ltd.20120—
+2K111245Heartnavigator Release 1Philips Medical Systems Nederland B.V.201139—
+3K261855Elucid PlaqueIQElucid Bioimaging, Inc.20260—
+3K252029AI-CVDHeartLung Corporation20250—
+3K250902HeartFlow AnalysisHeartFlow, Inc.20250—
+3K241524Elucid PlaqueIQElucid Bioimaging, Inc.20240—
+3K212758AutoplaqueCedars-Sinai Medical Center: Aim20233—
+3K213857HeartFlow AnalysisHeartFlow, Inc.20221—
+3K190868Cleerly LabsCleerly, Inc.20197—
+3K172418OpenSightNovarad Corporation20185—
+3K172162ACUSON S3000 S2000 S1000 Diagnostic Ultrasound SystemsSiemens Healthcare201743—
+3K171314QLAB Advanced Quantification SoftwarePhilips Health Care201745—
+3K170069AmCAD-UVAmcad Biomed Corporation20170—
+3K132524CT Transcatheter Aortic Valve Implantation (Tavi) Planning ApplicationPhilips Medical Systems201401
+3K140138Heartnavigator Release 2.0Philips Medical Systems Nederland B.V.20142—
+3K121296Interventional WorkspotPhilips Medical Systems Nederland B.V.20131—
+3K121781Echonavigator Release 1Philips Medical Systems Nederland B.V.201232—
+4K260497DEEPVESSEL PlaqueKeya Medical Technology Co., Ltd.20260—
+4K251027cvi42 Coronary Plaque Software ApplicationCircle Cardiovascular Imaging, Inc.20250—
+4K243884TavipilotCaranx Medical20250—
+4K242240CaRi-PlaqueCaristo Diagnostics, Ltd.20251—
+4K221796Cyware 4H and Cysart 4HAbys Medical20221—
+4K213128IntraOp VSP Software DeviceXironetic, LLC20221—
+4K220146VisARNovarad Corporation20220—
+4K210743ACUSON Redwood Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.2021153
+4K202683ACUSON Sequoia Diagnostic Ultrasound System, ACUSON SC2000 Diagnostic Ultrasound System…Siemens Medical Solutions USA, Inc.20206—
+4K202280Cleerly Labs v2.0Cleerly, Inc.20205—
+4K201462ACUSON Sequoia Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.2020241
+4K200707ACUSON Sequoia Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.202025—
+4K200713EchoNavigatorPhilips Medical Systems Nederland B.V.20202—
+4K193257ACUSON Sequoia Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.2020261
+4K183575ACUSON S3000, S2000 Diagnostic Ultrasound SystemSiemens Healthineers201926—
+4K181264QLAB Advanced Quantification SoftwarePhilips Ultrasound, Inc.201844—
+4K181177Interventional WorkspotPhilips Medical Systems Nederland B.V.20180—
+4K180799Clarius Ultrasound ScannerClarius Mobile Health Corp.201811—
+4K180067ACUSON X800 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.201828—
+4K172607Philips EPIQ 5 Diagnostic Ultrasound System, EPIQ 7 Diagnostic Ultrasound System…Philips Health Care20172831
+5K253786syngo.CT Coronary CockpitSiemens Medical Solutions USA, Inc.20260—
+5K260748ES-SeriesE-Scopics20260—
+5K251656Careverse CoronaryDoc (Careverse CoronaryDoc)Careverse Technology Pte., Ltd.20250—
+5K251837Salix Coronary Plaque (V1.0.0)Artrya Limited20250—
+5K250120GECHONarnar, LLC20250—
+5K243069Lumys (V1)Intradys20250—
+5K242338Cleerly LABS (v2.0)Cleerly, Inc.20252—
+5K243299ACUSON Redwood Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.20240—
+5K232189OrionXRHoth Intelligence, Inc.20230—
+5K221190ACUSON Juniper Diagnostic Ultrasound System and ACUSON Juniper Select Diagnostic…Siemens Medical Solutions USA, Inc.20224—
+5K221500ACUSON Sequoia Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.20226—
+5K221270EchoNavigator R4.0Philips Medical Systems Nederland B.V.20221—
+5K212851EchoSK and EchoSGyn modules for EchoS Family devicesEcholight S.P.A20220—
+5K213487ACUSON P500 Ultrasound SystemSiemens Medical Solutions USA, Inc.20221—
+5K211726Acuson SC2000 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.20214—
+5K211859ACUSON Sequoia Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.202171
+5K191647QLAB Advanced Quantification SoftwarePhilips Health Care201941—
+5K192107Clarius Ultrasound ScannerClarius Mobile Health Corp.201910—
+5K191922ACUSON P200 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.201923—
+5K190913QLAB Advanced Quantification Software 13Philips Health Care20191—
+5K181485EPIQ , EPIQ 5, EPIQ 7, Affiniti 30, Affiniti 50 and Affiniti 70 Diagnostic Ultrasound…Philips Ultrasound, Inc.20182724
+6K262548EPIQ Inspira Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound…Philips Ultrasound, LLC20260—
+6K261210Cleerly PlaqueCleerly, Inc.20260—
+6K260588Cleerly LABSCleerly, Inc.20260—
+6K253614EchoNavigator R5.0Philips Medical Systems Nederland B.V.20260—
+6K242893VERAFEYE System VERAFEYE Imaging Catheter & VERAFEYE Imaging SystemLuma Vision Limited20252—
+6K233613ACUSON SC2000 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.20240—
+6K233610ACUSON P500 Ultrasound System; ACUSON P500 ICE Ultrasound SystemSiemens Medical Solutions USA, Inc.20240—
+6K230207ACUSON Juniper Diagnostic Ultrasound System, ACUSON Juniper Select Diagnostic Ultrasound…Siemens Medical Solutions USA, Inc.20233—
+6K223735ACUSON Sequoia Diagnostic Ultrasound System, ACUSON Sequoia Select Diagnostic Ultrasound…Siemens Medical Solutions USA, Inc.20235—
+6K211665SONON Ultrasound Imaging System, Model: SONON300CHealcerion Co., Ltd.20220—
+6K212400SONON Ultrasound Imaging System, Model: SONON 500LHealcerion Co., Ltd.20220—
+6K220490ImaCor Zura Handheld ZHH-010Imacor, Inc.202202
+6K211746Pocket Ultrasound SystemGuangdong Youkey Medical Co., Ltd.20221—
+6K212012Follicle ClarityCycle Clarity20221—
+6K213436Clarius Ultrasound ScannerClarius Mobile Health Corp.20212—
+6K211161Critical Care Suite with Endotracheal Tube Positing AI algorithmGe Medical Systems, LLC20211—
+6K211232Apache Ultrasound SystemAco Healthcare Co., Ltd.20210—
+6K202074Apache Ultrasound System (Model C62)Compal Electronics, Inc.20200—
+6K2013523D Auto LAAPhilips Health Care20200—
+6K200356Medo AriaMedo.Ai20203—
+6K200974QLAB Advanced Quantification SoftwarePhilips Health Care202012—
+6K201012EPIQ Diagnostic Ultrasound System Series, Affiniti Diagnostic Ultrasound System Series…Philips Ultrasound, Inc.2020185
+6K200304EPIQ Diagnostic Ultrasound SystemPhilips Ultrasound, Inc.2020243
+6K182857EPIQ Diagnostic Ultrasound System, EPIQ 5 Diagnostic Ultrasound System, EPIQ 7…Philips Ultrasound, Inc.20181923
+7K261849VERAFEYE Imaging Catheter (VF-VIC-002)Luma Vision Limited20260—
+7K260885VERAFEYE Imaging and Guidance System (VF-VIS-002)Luma Vision Limited20260—
+7K252332FolliscanMim Fertility20260—
+7K253502Critical Care Suite with Enteric Tube Positioning AI AlgorithmGe Medical Systems, LLC20260—
+7K253457ACUSON Juniper Diagnostic Ultrasound System; ACUSON Juniper Select Diagnostic Ultrasound…Siemens Medical Solutions USA, Inc.20250—
+7K234042EFAI Bonesuite XR Bone Age Pro Assessment System (BAP-XR-100)Ever Fortune.Ai, Co., Ltd.20242—