510(k) Report

Devices descending from K073167

6 later devices reach Brainstat Software Option for GE Signa MR Scanner through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K080762IB Neuro, Version 1.0Imaging Biometrics, LLC20085—
+2K123302IB ClinicImaging Biometrics, LLC20131—
+2K120637Synapse 3D Brain PerfusionFujifilm Medical System U.S.A., Inc.20121—
+2K091444PerfscapeOlea Medical20090—
+3K211356GIQuantMotilent, Ltd.20210—
+3K162287Synapse 3D Perfusion AnalysisFujifilm Medical Systems U.S.A, Inc.20170—