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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, X-Ray, Extraoral Source, Digital
510(k) Number K200284
Device Name R-Sensor, R-Sensor
Applicant
Remedi Co., Ltd.
#1409, Is Biz Tower, 26 Yangpyeong-Ro 21
Seoul,  KR
Applicant Contact Jadon Koo
Correspondent
510K FDA, Inc.
100 E Granada Blvd.
Suite 219
Ormond Beach,  FL  32176
Correspondent Contact W. Lee Strong
Regulation Number872.1800
Classification Product Code
MUH  
Date Received02/05/2020
Decision Date 02/28/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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