510(k) Report

Devices descending from K112387

40 later devices reach Procedure Rehearsal Studio (TM) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K153705PROcedure Rehearsal Studio3Dsystems, Simbionix Products20160—
+1K140860ImmersiveTouch3 and MicrovisTouchImmersivetouch201401
+1K123023Surgery Rehearsal PlatformSurgical Theater, LLC201337—
+1K123269Procedure Rehearsal StudioSimbionix, Ltd.20131—
+2K170793SuRgical Planner (SRP)Surgical Theater, LLC201851
+2K142107Echo True 3D ViewerEchopixel, Inc.2015271
+2K140819Surgical Navigation Advanced PlatformSurgical Theater, LLC20141—
+3K201465SuRgical Planner (SRP) BrainStormSurgical Theater, Inc.202041
+3K190074Presero 3D Scanning SystemCertis Health20190—
+3K171356Clarity RevealCeevra, Inc.201718—
+3K170167True 3D Viewer SoftwareEchopixel, Inc.201761
+3K160584Surgical Navigation Advanced Platform (SNAP)Surgical Theater, LLC201604
+4K210344inVisionOSPrecisionos Technology, Inc.20210—
+4K203486OtoplanCascination AG20212—
+4K172418OpenSightNovarad Corporation20185—
+4K173274Ceevra Reveal 2.0Ceevra, Inc.201817—
+5K242120OtoplanCascination AG20250—
+5K222035Avatar Medical Software V1Avatar Medical20232—
+5K222676Ceevra Reveal 3Ceevra, Inc.20235—
+5K222458Aibolit 3D+Aibolit Technologies, LLC20230—
+5K221796Cyware 4H and Cysart 4HAbys Medical20221—
+5K213128IntraOp VSP Software DeviceXironetic, LLC20221—
+5K220300OtoplanCascination AG20220—
+5K220146VisARNovarad Corporation20220—
+5K211443Aibolit 3D+Aibolit Technologies, LLC20222—
+5K192890SentEPSentiar, Inc.20201—
+5K182643IRIS 1.0 SystemIntuitive Surgical20192—
+6K261677Artificial Intelligence Renal Assessment (AIRA) Version 1Aramis Global AI Consultancies, LLC20260—
+6K253950Avatar Medical VisionAvatar Medical20260—
+6K252091Surgical Reality ViewerMedicalvr B.V.20260—
+6K243069Lumys (V1)Intradys20250—
+6K242205SpectoMed (v1.0)Specto Medical20250—
+6K242461IRISegIntuitive Surgical, Inc.20241—
+6K232339Augmented Reality ApplicationSira Medical, Inc.20240—
+6K233568Ceevra Reveal 3+Ceevra, Inc.20232—
+6K232189OrionXRHoth Intelligence, Inc.20230—
+6K223290CommandEP Data Manager PC (DPC02), CommandEP HMD (HMD02)Sentiar, Inc.20230—
+7K251763IRISegIntuitive Surgical, Inc.20250—
+7K243933Ceevra Reveal 3+Ceevra, Inc.20251—
+8K261595Ceevra Reveal 4Ceevra, Inc.20260—