Galaxy R Digital Radiography Upgrade— 510(k) K172435

Name: FDA 510(k) clearance K172435
Creator: U.S. Food and Drug Administration
Published: 2017-10-13

Substantially Equivalent

Medien International Co, Ltd.

FDA 510(k) clearance K172435 for Galaxy R Digital Radiography Upgrade, Substantially Equivalent on 2017-10-13. Applicant: Medien International Co, Ltd.. Device class: 2.

Clearance details

Applicant: Medien International Co, Ltd.
Product code: Code MQB
Device class: Class 2
Regulation: 21 CFR 892.1680
Advisory panel: Radiology
Date received: 2017-08-11
Decision date: 2017-10-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Anyang-Si, KR

Download summary PDF View on FDA.gov ↗

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