DIGITAL FLAT PANEL X-RAY DETECTOR/1417PGA— 510(k) K122928

Name: FDA 510(k) clearance K122928
Creator: U.S. Food and Drug Administration
Published: 2013-01-30

Substantially Equivalent

Rayence Co., Ltd.

FDA 510(k) clearance K122928 for DIGITAL FLAT PANEL X-RAY DETECTOR/1417PGA, Substantially Equivalent on 2013-01-30. Applicant: Rayence Co., Ltd.. Device class: 2.

Clearance details

Applicant: Rayence Co., Ltd.
Product code: Code MQB
Device class: Class 2
Regulation: 21 CFR 892.1680
Advisory panel: Radiology
Date received: 2012-09-24
Decision date: 2013-01-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Houston, TX, US

Download summary PDF View on FDA.gov ↗

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