SOLID STATE X-RAY IMAGING DEVICE, DIGITAL FLAT PANEL X-RAY DETECTOR, 1417WGC— 510(k) K141563

Name: FDA 510(k) clearance K141563
Creator: U.S. Food and Drug Administration
Published: 2014-07-16

Substantially Equivalent

Rayence Co., Ltd.

FDA 510(k) clearance K141563 for SOLID STATE X-RAY IMAGING DEVICE, DIGITAL FLAT PANEL X-RAY DETECTOR, 1417WGC, Substantially Equivalent on 2014-07-16. 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: 2014-06-12
Decision date: 2014-07-16
Decision: Substantially Equivalent
Clearance type: Special
Location: Houston, TX, US

Download summary PDF View on FDA.gov ↗

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