510(k) Report

Devices descending from K080762

5 later devices reach IB Neuro, Version 1.0 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K123302IB ClinicImaging Biometrics, LLC20131—
+1K120637Synapse 3D Brain PerfusionFujifilm Medical System U.S.A., Inc.20121—
+1K091444PerfscapeOlea Medical20090—
+2K211356GIQuantMotilent, Ltd.20210—
+2K162287Synapse 3D Perfusion AnalysisFujifilm Medical Systems U.S.A, Inc.20170—