1717SGN / 1717SCN Digital Flat Panel X-ray Detector— 510(k) K150150

Substantially Equivalent

Rayence Co., Ltd.

FDA 510(k) clearance K150150 for 1717SGN / 1717SCN Digital Flat Panel X-ray Detector, Substantially Equivalent on 2015-03-27. Applicant: Rayence Co., Ltd..

Clearance details

Applicant: Rayence Co., Ltd.
Product code: Code MQB
Advisory panel: Radiology
Date received: 2015-01-23
Decision date: 2015-03-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hwaseong-Si, KR

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