Persyst ESI powered by Epilog

GUDID 05430000733045

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.

Clouds of Care

Bioelectrical signal analysis software
Primary Device ID05430000733045
NIH Device Record Keyfe707c54-6502-4a14-8ac9-3a9c59b33375
Commercial Distribution StatusIn Commercial Distribution
Brand NamePersyst ESI powered by Epilog
Version Model Numberv2
Company DUNS371252830
Company NameClouds of Care
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS105430000733021 [Previous]
GS105430000733045 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

OLXSource Localization Software For Electroencephalograph Or Magnetoencephalograph

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-06-22
Device Publish Date2023-06-14
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