RAYSCAN A-EXPERT 3D— 510(k) K131695

Substantially Equivalent

Ray Co., Ltd.

FDA 510(k) clearance K131695 for RAYSCAN A-EXPERT 3D, Substantially Equivalent on 2013-11-01. 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: 2013-06-10
Decision date: 2013-11-01
Decision: Substantially Equivalent
Clearance type: Special
Location: Santa Rosa, CA, US

Download summary PDF View on FDA.gov ↗

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