510(k) Report

Devices descending from K073468

141 later devices reach Mimics through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K202805Optimized Positioning System (OPS) InsightCorin USA20200—
+4K201052KLS Martin Individual Patient Solutions (IPS) Planning SystemKLS-Martin L.P.20200—
+4K193545Corin Optimized Positioning System (OPS) FemoralCorin USA20200—
+4K201465SuRgical Planner (SRP) BrainStormSurgical Theater, Inc.202041
+4K192979KLS Martin Individual Patient Solutions (IPS) Planning SystemKLS-Martin L.P.20202—
+4K190074Presero 3D Scanning SystemCertis Health20190—
+4K171356Clarity RevealCeevra, Inc.201718—
+4K170167True 3D Viewer SoftwareEchopixel, Inc.201761
+4K160584Surgical Navigation Advanced Platform (SNAP)Surgical Theater, LLC201604
+5K261641Lower Limb AI (LLAI)AI Planning Logic, Inc.20260—
+5K253308Materialise Personalized Guides and Models for Craniomaxillofacial Surgery CMF Titanium…Materialise NV20260—
+5K250369Axial3D InsightAxial Medical Printing Limited20250—
+5K250921CORIOGRAPH Pre-Op Planning and Modeling ServicesBlue Belt Technologies, Inc.20250—
+5K211614CenterMed Patient Matched Assisted Surgical Planning (ASP) SystemCentermed, Inc.20221—
+5K210344inVisionOSPrecisionos Technology, Inc.20210—
+5K203486OtoplanCascination AG20212—
+5K172418OpenSightNovarad Corporation20185—
+5K173274Ceevra Reveal 2.0Ceevra, Inc.201817—
+6K242120OtoplanCascination AG20250—
+6K223421MedCAD AccuPlan Orthopedics SystemMedcad20230—
+6K222035Avatar Medical Software V1Avatar Medical20232—
+6K222676Ceevra Reveal 3Ceevra, Inc.20235—
+6K222458Aibolit 3D+Aibolit Technologies, LLC20230—
+6K213128IntraOp VSP Software DeviceXironetic, LLC20221—
+6K220300OtoplanCascination AG20220—
+6K220146VisARNovarad Corporation20220—
+6K211443Aibolit 3D+Aibolit Technologies, LLC20222—
+6K192890SentEPSentiar, Inc.20201—
+6K182643IRIS 1.0 SystemIntuitive Surgical20192—
+7K261677Artificial Intelligence Renal Assessment (AIRA) Version 1Aramis Global AI Consultancies, LLC20260—
+7K253950Avatar Medical VisionAvatar Medical20260—
+7K252091Surgical Reality ViewerMedicalvr B.V.20260—
+7K242205SpectoMed (v1.0)Specto Medical20250—
+7K242461IRISegIntuitive Surgical, Inc.20241—
+7K232339Augmented Reality ApplicationSira Medical, Inc.20240—
+7K233568Ceevra Reveal 3+Ceevra, Inc.20232—
+7K232189OrionXRHoth Intelligence, Inc.20230—
+7K223290CommandEP Data Manager PC (DPC02), CommandEP HMD (HMD02)Sentiar, Inc.20230—
+8K251763IRISegIntuitive Surgical, Inc.20250—
+8K243933Ceevra Reveal 3+Ceevra, Inc.20251—
+9K261595Ceevra Reveal 4Ceevra, Inc.20260—