PreOp

GUDID 05430000733021

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.

Epilog

Bioelectrical signal analysis software

• Primary Device ID: 05430000733021
• NIH Device Record Key: 67abb55e-ed99-407c-b359-052b5822fe10
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PreOp
• Version Model Number: v2
• Company DUNS: 371461292
• Company Name: Epilog
• 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	05430000733007 [Previous]
GS1	05430000733021 [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: 2022-06-30
• Device Publish Date: 2022-06-22

On-Brand Devices [PreOp]

• 05430000733007: PreOp is intended for use by a trained/qualified EEG technologist or physician on both adult and
• 05430000733021: PreOp is active medical device software (MSDW) intended for use by a trained Epilog EEG technolo