510(k) Report

Devices descending from K162830

9 later devices reach SIS Software through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K230150OptimMRIRebrain, Sas20231—
+1K183019SIS Software version 3.3.0Surgical Information Sciences, Inc.20196—
+2K242054OptimMRI (v2)Rebrain, Sas20240—
+2K192304SIS Software Version 3.6.0Surgical Information Sciences, Inc.20195—
+3K210071SIS System (Version 5.1.0)Surgical Information Sciences, Inc.20214—
+4K223032SIS System (Version 5.6.0)Surgical Information Sciences, Inc.20223—
+5K230977SIS SystemSurgical Information Sciences, Inc.20232—
+6K241083SIS SystemSurgical Information Sciences, Inc.20241—
+7K261795Quicktome Software SuiteOmniscient Neurotechnology Pty, Ltd.20260—