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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 K222219
Device Name R2 Studio Q/RCT820
Applicant
Megagen Implant Co., Ltd.
45, Secheon-Ro, 7-Gil
Daegu,  KR 42921
Applicant Contact Yong Jae Kim
Correspondent
Megagen Implant Co., Ltd.
45, Secheon-Ro, 7-Gil
Daegu,  KR 42921
Correspondent Contact Yong Jae Kim
Regulation Number892.1750
Classification Product Code
OAS  
Date Received07/25/2022
Decision Date 12/06/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
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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