FDA.reportPublic FDA data

Bioelectrical signal analysis software

Definition
A software program intended to acquire, process, store and analyse biological electrical signals, both in real-time and delayed time, for diagnostic applications. The signals are typically provided by electrophysiological recording/monitoring [e.g., electromyography (EMG), electroencephalography (EEG), evoked potentials (EP), bioelectrical impedance analysis (BIA)]. It may be installed in the recording/monitoring device, personal computer, or data network server. It is neither intended for continuous bedside nor intraoperative monitoring, and is not dedicated to hearing analysis.
GUDID devices
64
Last updated
2026-06-04 19:44:10

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
00858703006276OmniFlow Therapy SystemACCELERATED CARE PLUS CORP100FLO2023-09-12
00860008953100SourcererBrain Electrophysiology Laboratory Company, LLC1.02025-10-20
09120109830269encevisAIT Austrian Institute of Technology GmbH2.1/2.22025-08-05
00850056774000NeuroMatchLVIS CORPORATION1.0.42025-04-04
00814901021558Blackrock NeuroPort Biopotential Signal Processing SystemBLACKROCK MICROSYSTEMS, LLC7.7.02025-02-14
00860005388110REMIEpitel, Inc.2.3.02022-12-16
00860005388158REMIEpitel, Inc.2.32022-12-16
00860005388189REMI VigilenzEpitel, Inc.1.x.x2024-03-11
00858703006375OmniTourACCELERATED CARE PLUS CORPOmniTourSoftware2023-09-12
00858703006313OmniFlow SoftwareACCELERATED CARE PLUS CORPFlowSoftware2023-09-06
00858703006337Synchrony Dysphagia Solutions by ACPACCELERATED CARE PLUS CORP300800A2023-09-01
00858703006320OmniMEACCELERATED CARE PLUS CORP100MTS2023-08-17
B485CNSENV1000CNS EnvisionNATUS NEUROLOGY INCORPORATED1.03.002023-08-18
00869732000166Persyst 15 EEG Review and Analysis SoftwarePersyst Development CorpP152023-07-24
00814901021497Blackrock NeuroPort Biopotential Signal Processing SystemBLACKROCK MICROSYSTEMS, LLC7.6.12023-07-14
05430000733045Persyst ESI powered by EpilogClouds of Carev22023-06-14
00814901021466Blackrock NeuroPort Biopotential Signal Processing SystemBLACKROCK MICROSYSTEMS, LLC7.6.02023-05-17
00853818007477MyoVision SoftwarePRECISION BIOMETRICS INCFeature Pack H2022-11-10
00814901021459Blackrock NeuroPort Biopotential Signal Processing SystemBLACKROCK MICROSYSTEMS, LLC7.5.22022-09-27
00814901021428Blackrock NeuroPort Biopotential Signal Processing SystemBLACKROCK MICROSYSTEMS, LLC7.5.02022-08-11
09120109830122encevisAIT Austrian Institute of Technology GmbH1.122022-07-15
05430000733021PreOpClouds of Carev22022-06-22
04251341900054HBIdbCORSCIENCE GmbH & Co. KGCS204012022-03-10
05694110068057Stratus EEGKvikna Medical ehf.Server Software2021-01-28
05694110068064Stratus EEGKvikna Medical ehf.Client Software2021-01-28
05694110068071Stratus EEGKvikna Medical ehf.Acquisition 2021-01-28
09120109830078encevisAIT Austrian Institute of Technology GmbH1.62021-01-11
B485VIS100CNS EnvisionMOBERG RESEARCH INCVIS-1002020-10-28
05430000733007PreOp Clouds of Care1.0.02020-10-01
05694110068040Stratus EEGKvikna Medical ehf.Web2020-09-01
08056446900642Galileo NT Line SoftwareEB NEURO SPAB86400530002020-05-25
B618Q1Coapt Evaluation KitCOAPT LLC12019-11-18
00814901020193Blackrock NeuroPort Biopotential Signal Processing SystemBLACKROCK MICROSYSTEMS, LLC6.5.42016-09-23
00814901020278Blackrock NeuroPort Biopotential Signal Processing SystemBLACKROCK MICROSYSTEMS, LLC7.0.02017-07-05
00814901020292Blackrock NeuroPort Biopotential Signal Processing SystemBLACKROCK MICROSYSTEMS, LLC7.0.22018-09-06
00814901020308Blackrock NeuroPort Biopotential Signal Processing SystemBLACKROCK MICROSYSTEMS, LLC7.0.32018-09-06
00814901020315Blackrock NeuroPort Biopotential Signal Processing SystemBLACKROCK MICROSYSTEMS, LLC7.0.42018-09-06
00817020020808SmartEP SoftwareINTELLIGENT HEARING SYSTEMS CORP.M8110002016-09-24
00817020020815SmartEP-ASSR SoftwareINTELLIGENT HEARING SYSTEMS CORP.M8110072016-09-24
00817020020822SmartScreener-Plus2 Screener LaunchINTELLIGENT HEARING SYSTEMS CORP.M8120022016-09-24
00817020020839SmartScreener-Plus2 AEP ModuleINTELLIGENT HEARING SYSTEMS CORP.M8120012016-09-24
00817020020846SmartScreener-Plus2 OAE ModuleINTELLIGENT HEARING SYSTEMS CORP.M8130102016-09-24
00817020020853SmartDPOAE SoftwareINTELLIGENT HEARING SYSTEMS CORP.M8130002016-09-24
00817020020860SmartTrOAE SoftwareINTELLIGENT HEARING SYSTEMS CORP.M8140002016-09-24
00817111020786Live View Panel Version 1.3Neurotronics, LLC1.32016-09-22
00853818007057MyoVision SoftwarePRECISION BIOMETRICS INCApricot2016-11-27
00853818007064MyoVision SoftwarePRECISION BIOMETRICS INCFeature Pack A2016-11-27
00853818007071MyoVision SoftwarePRECISION BIOMETRICS INCFeature Pack B2016-11-27
00853818007088MyoVision SoftwarePRECISION BIOMETRICS INCFeature Pack C2016-11-27
00853818007095MyoVision SoftwarePRECISION BIOMETRICS INCFeature Pack D2016-11-27
00853818007101MyoVision SoftwarePRECISION BIOMETRICS INCFeature Pack E2016-11-27
00853818007392MyoVision SoftwarePRECISION BIOMETRICS INCFeature Pack G2018-04-18
00869732000104Persyst 12 EEG Review and Analysis SoftwarePersyst Development CorpP122016-09-01
00869732000111Persyst 13 EEG Review and Analysis SoftwarePersyst Development CorpP132016-09-01
00869732000128Persyst 14 Review and Analysis SoftwarePersyst Development CorpP142019-04-08
00869732000135Persyst Mobile App Persyst Development CorpPersyst Mobile App2019-04-08
00869732000142Persyst Mobile AppPersyst Development CorpApp for Web2019-04-08
05694110063052Lifelines iEEG Client SoftwareKvikna Medical ehf.KSW20502016-10-03
05694110063069Lifelines iEEG Server SoftwareKvikna Medical ehf.KSW20602016-10-03
08033928120880micromedMICROMED SPASystemPlus EVOLUTION2018-03-21
08033928120958MicromedMICROMED SPABRAIN QUICK SOFTWARE2018-05-21
B006EMGVIEW0NONENeurovision Medical Products, Inc.NONE2016-09-24
B202BC0BCR.J.L. SCIENCES, INC.BC (Body Composition Software)2017-08-10
B202BCSEG0BCR.J.L. SCIENCES, INC.BC (Body Composition Software) Segmental2017-08-10