PreOp

Primary DI
05430000733021
Brand
PreOp
Company
Clouds of Care
Model
v2
Device description
PreOp is active medical device software (MSDW) intended for use by a trained Epilog EEG technologist / Operator in combination with Persyst EEG Review and Analysis Software on both adult and pediatric subjects at least 3 years of age for 3D visualization of the human brain function recorded with EEG and using a patient-specific MR image.
Published
2022-06-22
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
05430000733007PreviousGS10
05430000733021PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05430000733007054300007330075430000733007
05430000733021054300007330215430000733021

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
05430000733045Persyst ESI powered by Epilogv22023-06-14
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
05430000733045Persyst ESI powered by EpilogClouds of CareOLX2023-06-14
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