FDA Product Code OLX: Source Localization Software For Electroencephalograph Or Magnetoencephalograph
Correlation Of Electrical Activity Of The Brain Using Various Neuroimaging Modalities For Source-localization
Leading manufacturers include Megin OY, Brain Electrophysiology Laboratory Company, LLC and LVIS Corporation.
FDA 510(k) Cleared Source Localization Software For Electroencephalograph Or Magnetoencephalograph Devices (Product Code OLX)
About Product Code OLX - Regulatory Context
510(k) Submission Activity
24 total 510(k) submissions under product code OLX since 1990, with 24 receiving FDA clearance (average review time: 188 days).
Submission volume has increased in recent years - 3 submissions in the last 24 months compared to 1 in the prior period - suggesting growing market activity in this device classification.
FDA Review Time
Recent submissions under OLX have taken an average of 140 days to reach a decision - down from 195 days historically, suggesting improved FDA processing for this classification.
OLX devices are reviewed by the Neurology panel. Browse all Neurology devices →