510(k) Report

Devices descending from K070226

66 later devices reach Cardioct through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K133603Philips CT Dynamic Myocardial Perfusion (DMP) ApplicationPhilips Medical Systems20140—
+1K093269Procedure Rehearsal StudioSimbionix, Ltd.201041—
+1K0937033DIShina Systems, Ltd.20102—
+1K092747Philips Comprehensive Cardiac Analysis (Cca) - Plaque Assessment ToolPhilips Medical Systems (Cleveland), Inc.200919—
+2K240786AutoChamberHeartLung Corporation20241—
+2K153705PROcedure Rehearsal Studio3Dsystems, Simbionix Products20160—
+2K122429Vessel Analysis and Autoplaque for Ors VisualObject Research Systems (Ors), Inc.201216—
+2K112387Procedure Rehearsal Studio (TM)Simbionix, Ltd.201140—
+2K1125303DI Including CscoreShina Systems, Ltd.20111—
+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—
+3K140860ImmersiveTouch3 and MicrovisTouchImmersivetouch201401
+3K123023Surgery Rehearsal PlatformSurgical Theater, LLC201337—
+3K123269Procedure Rehearsal StudioSimbionix, Ltd.20131—
+3K1134423DIShina Systems, Ltd.20120—
+4K260497DEEPVESSEL PlaqueKeya Medical Technology Co., Ltd.20260—
+4K251027cvi42 Coronary Plaque Software ApplicationCircle Cardiovascular Imaging, Inc.20250—
+4K242240CaRi-PlaqueCaristo Diagnostics, Ltd.20251—
+4K202280Cleerly Labs v2.0Cleerly, Inc.20205—
+4K170793SuRgical Planner (SRP)Surgical Theater, LLC201851
+4K142107Echo True 3D ViewerEchopixel, Inc.2015271
+4K140819Surgical Navigation Advanced PlatformSurgical Theater, LLC20141—
+5K253786syngo.CT Coronary CockpitSiemens Medical Solutions USA, Inc.20260—
+5K251656Careverse CoronaryDoc (Careverse CoronaryDoc)Careverse Technology Pte., Ltd.20250—
+5K251837Salix Coronary Plaque (V1.0.0)Artrya Limited20250—
+5K242338Cleerly LABS (v2.0)Cleerly, Inc.20252—
+5K201465SuRgical Planner (SRP) BrainStormSurgical Theater, Inc.202041
+5K190074Presero 3D Scanning SystemCertis Health20190—
+5K171356Clarity RevealCeevra, Inc.201718—
+5K170167True 3D Viewer SoftwareEchopixel, Inc.201761
+5K160584Surgical Navigation Advanced Platform (SNAP)Surgical Theater, LLC201604
+6K261210Cleerly PlaqueCleerly, Inc.20260—
+6K260588Cleerly LABSCleerly, Inc.20260—
+6K210344inVisionOSPrecisionos Technology, Inc.20210—
+6K203486OtoplanCascination AG20212—
+6K172418OpenSightNovarad Corporation20185—
+6K173274Ceevra Reveal 2.0Ceevra, Inc.201817—
+7K242120OtoplanCascination AG20250—
+7K222035Avatar Medical Software V1Avatar Medical20232—
+7K222676Ceevra Reveal 3Ceevra, Inc.20235—
+7K222458Aibolit 3D+Aibolit Technologies, LLC20230—
+7K221796Cyware 4H and Cysart 4HAbys Medical20221—
+7K213128IntraOp VSP Software DeviceXironetic, LLC20221—
+7K220300OtoplanCascination AG20220—
+7K220146VisARNovarad Corporation20220—
+7K211443Aibolit 3D+Aibolit Technologies, LLC20222—
+7K192890SentEPSentiar, Inc.20201—
+7K182643IRIS 1.0 SystemIntuitive Surgical20192—
+8K261677Artificial Intelligence Renal Assessment (AIRA) Version 1Aramis Global AI Consultancies, LLC20260—
+8K253950Avatar Medical VisionAvatar Medical20260—
+8K252091Surgical Reality ViewerMedicalvr B.V.20260—
+8K243069Lumys (V1)Intradys20250—
+8K242205SpectoMed (v1.0)Specto Medical20250—
+8K242461IRISegIntuitive Surgical, Inc.20241—
+8K232339Augmented Reality ApplicationSira Medical, Inc.20240—
+8K233568Ceevra Reveal 3+Ceevra, Inc.20232—
+8K232189OrionXRHoth Intelligence, Inc.20230—
+8K223290CommandEP Data Manager PC (DPC02), CommandEP HMD (HMD02)Sentiar, Inc.20230—
+9K251763IRISegIntuitive Surgical, Inc.20250—
+9K243933Ceevra Reveal 3+Ceevra, Inc.20251—
+10K261595Ceevra Reveal 4Ceevra, Inc.20260—