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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, Stationary
510(k) Number K230241
Device Name Jumong General
Applicant
Sg Healthcare Co, Ltd.
10 Yongnyeong-Ro, Moga-Myeon Ichen-Si
Seoul,  KR 17408
Applicant Contact Byung Ju Kang
Correspondent
Kamm & Associates
8870 Ravello Ct.
Naples,  FL  34114
Correspondent Contact Daniel Kamm
Regulation Number892.1680
Classification Product Code
KPR  
Subsequent Product Code
MQB  
Date Received01/30/2023
Decision Date 02/23/2023
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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