510(k) Report

Devices descending from K132108

27 later devices reach MAXIO through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K223758EpioneQuantum Surgical Sas202302
+1K211645EpioneQuantum Surgical Sas20221—
+1K191332XACT Robotic SystemXact Robotics, Ltd.20193—
+1K152473CAS-One IRCascination AG20163—
+1K150313Ablation ConfirmationNeuwave Medical, Inc.201516—
+2K232022CAS-One IRCascination AG20241—
+2K202297Aline Ablation IntelligenceMirada Medical, Ltd.202011—
+2K201586XACT Robotic SystemXact Robotics, Ltd.20202—
+2K163643Sirio H3Masmec Spa20170—
+2K161285Ablation ConfirmationNeuwave Medical, Inc.20163—
+3K261225CAS-One IRCascination AG20260—
+3K240796myAblation Guide (VB80A)Siemens Healthcare GmbH20241—
+3K222938Ablation-fitR.a.W. S.R.L20230—
+3K223639VisAble.IOTechsomed20232—
+3K220256MIM-AblationMim Software, Inc.20224—
+3K213759XACT Robotic System, ACE ModelXact Robotics, Ltd.20220—
+3K221116XACT ACE Robotic SystemXact Robotics, Ltd.20220—
+3K171022Ablation ConfirmationNeuwave Medical, Inc.20172—
+4K253264myAblation Guide (VC10A)Siemens Healthcare GmbH20260—
+4K232862MIM – Monte Carlo DosimetryMim Software, Inc.20242—
+4K232514MIM – Dose AnalysisMim Software, Inc.20240—
+4K240773VisAble.IOTechsomed20241—
+4K192427Ablation ConfirmationNeuwave Medical, Inc.20191—
+5K251931BioTraceIO Vision (V1.7)Techsomed Medical Technologies20250—
+5K243012MIM – Symphony HDR FusionMim Software, Inc.20241—
+5K232227Ablate-IQNeuwave Medical, Inc.20240—
+6K251883MIM – LesionID ProMim Software, Inc.20250—