Persyst ESI powered by Epilog

Primary DI
05430000733045
Brand
Persyst ESI powered by Epilog
Company
Clouds of Care
Model
v2
Device description
Persyst ESI powered by Epilog provides Electrical Source Imaging as a service to a clinical user. The clinical user does not interact directly with the device. In the Persyst ESI powered by Epilog service, the device is used by Epilog operators to generate a report.Persyst ESI powered by Epilog is intended for use by a trained/qualified EEG technologist or physician on both adult and pediatric subjects at least 3 years of age for the visualization of human brain function by fusing a variety of EEG information with rendered images of an individualized head model and an individualized MRI image.
Published
2023-06-14
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
OLXSource Localization Software For Electroencephalograph Or Magnetoencephalograph

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OLXSource Localization Software For Electroencephalograph Or MagnetoencephalographNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K172858000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K172858000PreOpEpilog2018-01-08OLX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05430000733021PreviousGS10
05430000733045PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05430000733021054300007330215430000733021
05430000733045054300007330455430000733045

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
371252830
Device count
1

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05430000733038Persyst ESI powered by Epilogv32026-04-20
05430000733021PreOpv22022-06-22
05430000733007PreOp 1.0.02020-10-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850056774017NeuroMatchLVIS CORPORATIONOLX2026-05-12
05430000733038Persyst ESI powered by EpilogClouds of CareOLX2026-04-20
09342451002433Compumedics CurryCOMPUMEDICS LIMITEDOLX2026-03-12
00860008953100SourcererBrain Electrophysiology Laboratory Company, LLCOLX2025-10-20
06430056480404MEGreview™Megin OyOLX2025-05-23
06430056480411TRIUX™ neoMegin OyOLX2025-05-23
00869732000166Persyst 15 EEG Review and Analysis SoftwarePersyst Development CorpOLX2023-07-24
05430000733021PreOpClouds of CareOLX2022-06-22
00850033571028GeoSource 2.0 Source Estimation SoftwareMagstim, Inc.OLX2022-01-25
05430000733007PreOp Clouds of CareOLX2020-10-01
04961311926266RICOH MEGRICOH COMPANY,LTD.OLX2018-03-07
00863003000343GeoSourceELECTRICAL GEODESICS, INC.OLX2016-10-04
06430056480008Elekta Neuromag® TRIUXMegin OyOLX2016-09-23
06430056480015Elekta Neuromag® TRIUXMegin OyOLX2016-09-23
06430056480022Data analysis software 3.4Megin OyOLX2016-09-23