Galaxy R Digital Radiography Upgrade— 510(k) K172435

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..

Clearance details

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

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