RIS500— 510(k) K143000

Substantially Equivalent

Ray Co., Ltd.

FDA 510(k) clearance K143000 for RIS500, Substantially Equivalent on 2015-01-23. Applicant: Ray Co., Ltd.. Device class: 2.

Clearance details

Applicant: Ray Co., Ltd.
Product code: Code MQB
Device class: Class 2
Regulation: 21 CFR 892.1680
Advisory panel: Radiology
Date received: 2014-10-17
Decision date: 2015-01-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hwaseong-Si, KR

Download summary PDF View on FDA.gov ↗

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