1717SGC_127um and 1717SGC_140um— 510(k) K171419

Name: FDA 510(k) clearance K171419
Creator: U.S. Food and Drug Administration
Published: 2017-06-09

Substantially Equivalent

Rayence Co., Ltd.

FDA 510(k) clearance K171419 for 1717SGC_127um and 1717SGC_140um, Substantially Equivalent on 2017-06-09. Applicant: Rayence Co., Ltd.. Device class: 2.

Clearance details

Applicant: Rayence Co., Ltd.
Product code: Code MQB
Device class: Class 2
Regulation: 21 CFR 892.1680
Advisory panel: Radiology
Date received: 2017-05-15
Decision date: 2017-06-09
Decision: Substantially Equivalent
Clearance type: Special
Location: Hwaseong-Si, KR

Download summary PDF View on FDA.gov ↗

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