PreOp

Primary DI
05430000733007
Brand
PreOp
Company
Clouds of Care
Model
1.0.0
Device description
PreOp is intended for use by a trained/qualified EEG technologist or physician on both adult and pediatric subjects at least3 years of age for the visualization of human brain function by fusing a variety of EEG information with rendered imagesof an individualized head model and an individualized MRI image.
Published
2020-10-01
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true

Contact Domains#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05430000733007PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05430000733007054300007330075430000733007

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

Contacts#

Phone, Email table
PhoneEmail
+1 (800) 687-0416info@epilog.care

Regulatory Flags#

DUNS number
371252830
Device count
1
Premarket exempt
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05430000733038Persyst ESI powered by Epilogv32026-04-20
05430000733045Persyst ESI powered by Epilogv22023-06-14
05430000733021PreOpv22022-06-22

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
05430000733045Persyst ESI powered by EpilogClouds of CareOLX2023-06-14
05430000733021PreOpClouds of CareOLX2022-06-22
00850033571028GeoSource 2.0 Source Estimation SoftwareMagstim, Inc.OLX2022-01-25
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