PORTABLE X-RAY SYSTEM, MODEL PORT-X II— 510(k) K063121

Name: FDA 510(k) clearance K063121
Creator: U.S. Food and Drug Administration
Published: 2007-01-11

Substantially Equivalent

Genoray Co., Ltd.

FDA 510(k) clearance K063121 for PORTABLE X-RAY SYSTEM, MODEL PORT-X II, Substantially Equivalent on 2007-01-11. Applicant: Genoray Co., Ltd.. Device class: 2.

Clearance details

Applicant: Genoray Co., Ltd.
Product code: Code EHD
Device class: Class 2
Regulation: 21 CFR 872.1800
Advisory panel: Dental
Date received: 2006-10-12
Decision date: 2007-01-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Flintville, TN, US

Download summary PDF View on FDA.gov ↗

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