510(k) Report

Devices descending from K131383

14 later devices reach X10 Headset with X-Series Basic Software, X24 Headset with X-Series Basic… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K233403Flexset SystemZeto, Inc.20241—
+1K200705Nurochek SystemCryptych Pty, Ltd.20200—
+1K172735WR19 SystemZeto, Inc.20183—
+1K170138NeuronauteBioserenity20170—
+1K141316Cognision Eeg/EP SystemNeuronetrix Solutions20157—
+2K260455New Wave SystemZeto, Inc.20260—
+2K220056iSyncWaveiMediSync, Inc.20220—
+2K213900WAVi SCAN EEG System and AccessoriesWavi Co.20220—
+2K192753NeuralScan SystemMedeia, Inc.20203—
+2K171781eVox SystemEvoke Neuroscience, Inc.20176—
+3K253767UB ERP SystemUniversal Brain20260—
+3K240420NeuroField Analysis SuiteNeurofield, Inc.20240—
+3K221959Q21Neurofield, Inc.20230—
+3K221963Cumulus Functional Neurophysiology PlatformCumulus Neuroscience Limited20231—