DIGITAL FLAT PANEL X-RAY DETECTOR— 510(k) K112558

Name: FDA 510(k) clearance K112558
Creator: U.S. Food and Drug Administration
Published: 2011-11-10

Substantially Equivalent

Samsung Mobile Display Co., Ltd.

FDA 510(k) clearance K112558 for DIGITAL FLAT PANEL X-RAY DETECTOR, Substantially Equivalent on 2011-11-10. Applicant: Samsung Mobile Display Co., Ltd.. Device class: 2.

Clearance details

Applicant: Samsung Mobile Display Co., Ltd.
Product code: Code MQB
Device class: Class 2
Regulation: 21 CFR 892.1680
Advisory panel: Radiology
Date received: 2011-09-02
Decision date: 2011-11-10
Decision: Substantially Equivalent
Clearance type: Special
Location: Houston, TX, US

Download summary PDF View on FDA.gov ↗

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