Cleared Traditional

PreOp

K172858 · Epilog · Neurology

Jan 2018

Decision

110d

Days

Class 2

Risk

About This 510(k) Submission

K172858 is an FDA 510(k) clearance for the PreOp, a Source Localization Software For Electroencephalograph Or Magnetoencephalograph (Class II — Special Controls, product code OLX), submitted by Epilog (Ghent, BE). The FDA issued a Cleared decision on January 8, 2018, 110 days after receiving the submission on September 20, 2017. This device falls under the Neurology review panel. Regulated under 21 CFR 882.1400.

Submission Details

510(k) Number	K172858 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 20, 2017
Decision Date	January 08, 2018
Days to Decision	110 days
Submission Type	Traditional
Review Panel	Neurology (NE)
Summary	Summary PDF

Device Classification

Product Code	OLX — Source Localization Software For Electroencephalograph Or Magnetoencephalograph
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 882.1400
Definition	Correlation Of Electrical Activity Of The Brain Using Various Neuroimaging Modalities For Source-localization