1012WCC, 1012WGC— 510(k) K162518

Substantially Equivalent

Rayence Co., Ltd.

FDA 510(k) clearance K162518 for 1012WCC, 1012WGC, Substantially Equivalent on 2016-10-06. Applicant: Rayence Co., Ltd..

Clearance details

Applicant: Rayence Co., Ltd.
Product code: Code MQB
Advisory panel: Radiology
Date received: 2016-09-09
Decision date: 2016-10-06
Decision: Substantially Equivalent
Clearance type: Special
Location: Hwaseong-Si, KR

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