FDA.reportPublic FDA data

CNS Envision

Primary DI
B485VIS100
Brand
CNS Envision
Company
MOBERG RESEARCH INC
Model
VIS-100
Device description
Software for use in the review, annotation and analysis of patient data collected using external physiological monitors.
Published
2020-10-28
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
OLTNon-Normalizing Quantitative Electroencephalograph Software
OMAAmplitude-Integrated Electroencephalograph
ORTBurst Suppression Detection Software For Electroencephalograph

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OLTNon-Normalizing Quantitative Electroencephalograph SoftwareNeurology2
OMAAmplitude-Integrated ElectroencephalographNeurology2
ORTBurst Suppression Detection Software For ElectroencephalographNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K192572000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K192572000CNS EnvisionMoberg Research, Inc.2019-12-17OLT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B485VIS100PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Bioelectrical signal analysis softwareA 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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
029957656
Device count
1

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B485CNS3501Component Neuromonitoring SystemCNS-3502021-02-12
B485CNS3001Component Neuromonitoring SystemCNS-3002017-12-21
B485CNS3101Component Neuromonitoring SystemCNS-3102017-12-21
B485CNS3201Component Neuromonitoring SystemCNS-3202017-12-21
B485CNSEEG2001Component Neuromonitoring SystemCNS-EEG-2002017-12-21
B485CNSEEG2101Component Neuromonitoring SystemCNS-EEG-2102017-12-21
B485CNSEEG2201Component Neuromonitoring SystemCNS-EEG-2202017-12-21
B485CNSEEG3001Component Neuromonitoring SystemCNS-EEG-3002017-12-21
B485CNSEEG3101Component Neuromonitoring SystemCNS-EEG-3102017-12-21
B485CNSEEG3201Component Neuromonitoring SystemCNS-EEG-3202017-12-21
B485CNSINX3001Component Neuromonitoring SystemCNS-INX-3002018-06-06
B485CNSINX3101Component Neuromonitoring SystemCNS-INX-3102018-06-06
B485CNSINX3201Component Neuromonitoring SystemCNS-INX-3202018-06-06
B485CNSPTZ3501Component Monitoring SystemCNS-PTZ-3502021-04-19
B485CNSVID3501Component Monitoring SystemCNS-VID-3502020-10-31
B485CNSVID3701Component Monitoring SystemCNS-VID-3702020-10-23
B485CNSVID3001Component Neuromonitoring SystemCNS-VID-3002017-12-21
B485CNSVID3101Component Neuromonitoring SystemCNS-VID-3102017-12-21
B485CNSVID3201Component Neuromonitoring SystemCNS-VID-3202017-12-21
B485CNSPTZ3001Component Neuromonitoring SystemCNS-PTZ-3002019-03-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B592SW100WAVi Scan SoftwareWAVI CO.OLT2026-03-25
B592WD100WAVi Electrical Processing UnitWAVI CO.OLT2026-03-25
B592WK200WAVi Scan KitWAVI CO.OLT2026-03-25
09120109830269encevisAIT Austrian Institute of Technology GmbHOMA2025-08-05
09120109830269encevisAIT Austrian Institute of Technology GmbHOLT2025-08-05
08056446901106NExT-DOCKINGEB NEURO SPAOLT2025-05-22
08056446901113NExT-PADEB NEURO SPAOLT2025-05-22
08056446901120NExT-AMP-ADVANCEDEB NEURO SPAOLT2025-05-22
08056446901137NExT-HSEB NEURO SPAOLT2025-05-22
08056446901168NExT-AMPEB NEURO SPAOLT2025-05-22
08056446901199NExT-ASEB NEURO SPAOLT2025-05-22
08056446901205NExT StationEB NEURO SPAOLT2025-05-22
08056446901090NExT Station AdvancedEB NEURO SPAOLT2025-05-19
08690020003062BrainView NeuralScanMedeia, Inc.OLT2025-02-05
08056446900673Neurotravel LIGHTEB NEURO SPAOLT2024-12-04
08056446901311BE PLUS PRO [LIGHT] EB NEURO SPAOLT2024-12-04
08056446901328BE PLUS PRO [STANDARD]EB NEURO SPAOLT2024-12-04
08056446901335BE PLUS PRO [FULL]EB NEURO SPAOLT2024-12-04
08056446901342BE PLUS PRO [ADVANCED]EB NEURO SPAOLT2024-12-04
10841522108754UltraviewSLSPACELABS HEALTHCARE (WASHINGTON), INCORT2024-05-13
00817111021264Live View Panel Pro Version 2.0Neurotronics, LLCOLT2024-05-09
10884521808270BISCovidien LPOLT2024-04-28
10884521808270BISCovidien LPORT2024-04-28
10884521808300BISCovidien LPORT2024-04-28
10884521808300BISCovidien LPOLT2024-04-28
10884521808317BISCovidien LPORT2024-04-28
10884521808317BISCovidien LPOLT2024-04-28
10197106549971CARDINAL HEALTHCardinal Health 200, LLCOMA2024-02-12
B485CNSENV1000CNS EnvisionNATUS NEUROLOGY INCORPORATEDOLT2023-08-18
B485CNSENV1000CNS EnvisionNATUS NEUROLOGY INCORPORATEDOMA2023-08-18