Cleared Traditional

RICOH MEG

K210199 · Ricoh Company, Ltd. · Neurology
Jul 2021
Decision
158d
Days
Class 2
Risk

About This 510(k) Submission

K210199 is an FDA 510(k) clearance for the RICOH MEG, a Source Localization Software For Electroencephalograph Or Magnetoencephalograph (Class II — Special Controls, product code OLX), submitted by Ricoh Company, Ltd. (Kanazawa-Shi, JP). The FDA issued a Cleared decision on July 2, 2021, 158 days after receiving the submission on January 25, 2021. This device falls under the Neurology review panel. Regulated under 21 CFR 882.1400.

Submission Details

510(k) Number K210199 FDA.gov
FDA Decision Cleared SESE
Date Received January 25, 2021
Decision Date July 02, 2021
Days to Decision 158 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