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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
Applicant
RAY Co., Ltd
332-7, Samsung 1-ro
Hwaseong-si,  KR 18380
Applicant Contact Changhwan Lee
Correspondent
RAY Co., Ltd
332-7, Samsung 1-ro
Hwaseong-si,  KR 18380
Correspondent Contact Changhwan Lee
Regulation Number892.1750
Classification Product Code
OAS  
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
Predetermined Change
Control Plan Authorized		 No
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