RAYSCAN a-Expert3D— 510(k) K190812

Substantially Equivalent

Ray Co., Ltd.

FDA 510(k) clearance K190812 for RAYSCAN a-Expert3D, Substantially Equivalent on 2019-04-24. Applicant: Ray Co., Ltd.. Device class: 2.

Clearance details

Applicant: Ray Co., Ltd.
Product code: Code OAS
Device class: Class 2
Regulation: 21 CFR 892.1750
Advisory panel: Radiology
Date received: 2019-03-29
Decision date: 2019-04-24
Decision: Substantially Equivalent
Clearance type: Special
Location: Hwaseong-Si, KR

Download summary PDF View on FDA.gov ↗

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