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

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• Primary Device ID: 05430000733045
• NIH Device Record Key: fe707c54-6502-4a14-8ac9-3a9c59b33375
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Persyst ESI powered by Epilog
• Version Model Number: v2
• Company DUNS: 371252830
• Company Name: Clouds of Care
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	05430000733021 [Previous]
GS1	05430000733045 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K172858

FDA Product Code

• OLX: Source Localization Software For Electroencephalograph Or Magnetoencephalograph

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-06-22
• Device Publish Date: 2023-06-14