FDA.reportPublic FDA data

encevis

Primary DI
09120109830078
Brand
encevis
Company
AIT Austrian Institute of Technology GmbH
Model
1.6
Device description
encevis is a quantitative EEG trending, spike and seizure detection software. encevis is used for both monitoring and trending of EEG recordings during acquisition and reviewing of processed recordings.
Published
2021-01-11
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
OLTNon-Normalizing Quantitative Electroencephalograph Software
OMAAmplitude-Integrated Electroencephalograph
OMBAutomatic Event Detection Software For Full-Montage Electroencephalograph

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OLTNon-Normalizing Quantitative Electroencephalograph SoftwareNeurology2
OMAAmplitude-Integrated ElectroencephalographNeurology2
OMBAutomatic Event Detection Software For Full-Montage ElectroencephalographNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K171720000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K171720000encevisAit Austrian Institute of Technology GmbH2018-04-19OMB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
09120109830078PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
09120109830078091201098300789120109830078

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
300281748
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
09120109830269encevis2.1/2.22025-08-05
09120109830122encevis1.122022-07-15

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
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00840067103517Cadwell GuardianCADWELL INDUSTRIES, INC.OLT2024-06-21
00840067103524Cadwell GuardianCADWELL INDUSTRIES, INC.OLT2024-06-21
00817111021264Live View Panel Pro Version 2.0Neurotronics, LLCOLT2024-05-09
10884521808270BISCovidien LPOLT2024-04-28
10884521808300BISCovidien LPOLT2024-04-28