VOLUX 21C, DIGITAL EXTRAORAL SOURCE X-RAY SYSTEM— 510(k) K120263

Name: FDA 510(k) clearance K120263
Creator: U.S. Food and Drug Administration
Published: 2012-07-10

Substantially Equivalent

Genoray Co., Ltd.

FDA 510(k) clearance K120263 for VOLUX 21C, DIGITAL EXTRAORAL SOURCE X-RAY SYSTEM, Substantially Equivalent on 2012-07-10. Applicant: Genoray Co., Ltd.. Device class: 2.

Clearance details

Applicant: Genoray Co., Ltd.
Product code: Code MUH
Device class: Class 2
Regulation: 21 CFR 872.1800
Advisory panel: Dental
Date received: 2012-01-30
Decision date: 2012-07-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Orange, CA, US

Download summary PDF View on FDA.gov ↗

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