Cleared Traditional

VOLUX, DIGITAL EXTRAORAL SOURCE X-RAY SYSTEM

K092171 · Genoray Co., Ltd. · Radiology
Apr 2010
Decision
279d
Days
Class 2
Risk

About This 510(k) Submission

K092171 is an FDA 510(k) clearance for the VOLUX, 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 April 26, 2010, 279 days after receiving the submission on July 21, 2009. This device falls under the Radiology review panel. Regulated under 21 CFR 872.1800.

Submission Details

510(k) Number K092171 FDA.gov
FDA Decision Cleared SESE
Date Received July 21, 2009
Decision Date April 26, 2010
Days to Decision 279 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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