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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name x-ray, tomography, computed, dental
510(k) Number K190812
Device Name RAYSCAN a-Expert3D
RAY Co., Ltd
332-7, Samsung 1-ro
Hwaseong-si,  KR 18380
Applicant Contact Changhwan Lee
RAY Co., Ltd
332-7, Samsung 1-ro
Hwaseong-si,  KR 18380
Correspondent Contact Changhwan Lee
Regulation Number892.1750
Classification Product Code
Date Received03/29/2019
Decision Date 04/24/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No