510(k) Report

Devices descending from K130013

17 later devices reach X4 System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K152040X8 System - Sleep Profiler (SP40), X8 System - Sleep Profiler PSG2 (SP29), X8 System -…Advanced Brain Monitoring, Inc.20151—
+1K131383X10 Headset with X-Series Basic Software, X24 Headset with X-Series Basic SoftwareAdvanced Brain Monitoring, Inc.201314—
+2K233403Flexset SystemZeto, Inc.20241—
+2K213007Cerebra Sleep SystemCerebra Medical, Ltd.20220—
+2K200705Nurochek SystemCryptych Pty, Ltd.20200—
+2K172735WR19 SystemZeto, Inc.20183—
+2K170138NeuronauteBioserenity20170—
+2K141316Cognision Eeg/EP SystemNeuronetrix Solutions20157—
+3K260455New Wave SystemZeto, Inc.20260—
+3K220056iSyncWaveiMediSync, Inc.20220—
+3K213900WAVi SCAN EEG System and AccessoriesWavi Co.20220—
+3K192753NeuralScan SystemMedeia, Inc.20203—
+3K171781eVox SystemEvoke Neuroscience, Inc.20176—
+4K253767UB ERP SystemUniversal Brain20260—
+4K240420NeuroField Analysis SuiteNeurofield, Inc.20240—
+4K221959Q21Neurofield, Inc.20230—
+4K221963Cumulus Functional Neurophysiology PlatformCumulus Neuroscience Limited20231—