WV3000T DIGITAL X-RAY DIRECT IMAGING FLAT PANEL DETECTOR SYSTEM— 510(k) K110801

Name: FDA 510(k) clearance K110801
Creator: U.S. Food and Drug Administration
Published: 2011-08-02

Substantially Equivalent

Direct Digital Imaging Technology (Beijing), Inc.

FDA 510(k) clearance K110801 for WV3000T DIGITAL X-RAY DIRECT IMAGING FLAT PANEL DETECTOR SYSTEM, Substantially Equivalent on 2011-08-02. Applicant: Direct Digital Imaging Technology (Beijing), Inc.. Device class: 2.

Clearance details

Applicant: Direct Digital Imaging Technology (Beijing), Inc.
Product code: Code MQB
Device class: Class 2
Regulation: 21 CFR 892.1680
Advisory panel: Radiology
Date received: 2011-03-23
Decision date: 2011-08-02
Decision: Substantially Equivalent
Clearance type: Special
Location: Beijing, CN

Download summary PDF View on FDA.gov ↗

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