1212FCA— 510(k) K202722

Substantially Equivalent

Rayence Co., Ltd.

FDA 510(k) clearance K202722 for 1212FCA, Substantially Equivalent on 2020-10-26. Applicant: Rayence Co., Ltd..

Clearance details

Applicant: Rayence Co., Ltd.
Product code: Code MQB
Advisory panel: Radiology
Date received: 2020-09-17
Decision date: 2020-10-26
Decision: Substantially Equivalent
Clearance type: Special
Location: Hwaseong-Si, KR

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