Aura DR 43C-AG flat panel detector— 510(k) K151014

Name: FDA 510(k) clearance K151014
Creator: U.S. Food and Drug Administration
Published: 2015-07-13

Substantially Equivalent

Abyzr Co., Ltd.

FDA 510(k) clearance K151014 for Aura DR 43C-AG flat panel detector, Substantially Equivalent on 2015-07-13. Applicant: Abyzr Co., Ltd.. Device class: 2.

Clearance details

Applicant: Abyzr Co., Ltd.
Product code: Code MQB
Device class: Class 2
Regulation: 21 CFR 892.1680
Advisory panel: Radiology
Date received: 2015-04-16
Decision date: 2015-07-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hwaseong-Si, KR

Download summary PDF View on FDA.gov ↗

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