510(k) Report

Devices descending from K120447

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K130013X4 SystemAdvanced Brain Monitoring, Inc.201317—
+2K152040X8 System - Sleep Profiler (SP40), X8 System - Sleep Profiler PSG2 (SP29), X8 System -…Advanced Brain Monitoring, Inc.20151—
+2K131383X10 Headset with X-Series Basic Software, X24 Headset with X-Series Basic SoftwareAdvanced Brain Monitoring, Inc.201314—
+3K233403Flexset SystemZeto, Inc.20241—
+3K213007Cerebra Sleep SystemCerebra Medical, Ltd.20220—
+3K200705Nurochek SystemCryptych Pty, Ltd.20200—
+3K172735WR19 SystemZeto, Inc.20183—
+3K170138NeuronauteBioserenity20170—
+3K141316Cognision Eeg/EP SystemNeuronetrix Solutions20157—
+4K260455New Wave SystemZeto, Inc.20260—
+4K220056iSyncWaveiMediSync, Inc.20220—
+4K213900WAVi SCAN EEG System and AccessoriesWavi Co.20220—
+4K192753NeuralScan SystemMedeia, Inc.20203—
+4K171781eVox SystemEvoke Neuroscience, Inc.20176—
+5K253767UB ERP SystemUniversal Brain20260—
+5K240420NeuroField Analysis SuiteNeurofield, Inc.20240—
+5K221959Q21Neurofield, Inc.20230—
+5K221963Cumulus Functional Neurophysiology PlatformCumulus Neuroscience Limited20231—