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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 K213226
Device Name RCT700
Applicant
RAY Co., Ltd
332-7, Samsung 1-ro
Hwaseong-si,  KR 18380
Applicant Contact Youna Im
Correspondent
RAY Co., Ltd
332-7, Samsung 1-ro
Hwaseong-si,  KR 18380
Correspondent Contact Youna Im
Regulation Number892.1750
Classification Product Code
OAS  
Date Received09/29/2021
Decision Date 11/29/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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