Cleared Traditional

VOLUX 21C, DIGITAL EXTRAORAL SOURCE X-RAY SYSTEM

K120263 · Genoray Co., Ltd. · Radiology
Jul 2012
Decision
162d
Days
Class 2
Risk

About This 510(k) Submission

K120263 is an FDA 510(k) clearance for the VOLUX 21C, DIGITAL EXTRAORAL SOURCE X-RAY SYSTEM, a System, X-ray, Extraoral Source, Digital (Class II — Special Controls, product code MUH), submitted by Genoray Co., Ltd. (Orange, US). The FDA issued a Cleared decision on July 10, 2012, 162 days after receiving the submission on January 30, 2012. This device falls under the Radiology review panel. Regulated under 21 CFR 872.1800.

Submission Details

510(k) Number K120263 FDA.gov
FDA Decision Cleared SESE
Date Received January 30, 2012
Decision Date July 10, 2012
Days to Decision 162 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF

Device Classification

Product Code MUH — System, X-ray, Extraoral Source, Digital
Device Class Class II — Special Controls
CFR Regulation 21 CFR 872.1800

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