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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 K230800
Device Name XVISION-525, HORIZON, HI-300, HI-500, SATURN-F PF32, SATURN-F PF40, SATURN-F PF50
Applicant
GEMSS HEALTHCARE CO., LTD.
1f, 822, Bogwang-Ro, Gwangtan-Myeon
Paju-Si,  KR 10952
Applicant Contact Jiho Park
Correspondent
GEMSS HEALTHCARE CO., LTD.
1f, 822, Bogwang-Ro, Gwangtan-Myeon
Paju-Si,  KR 10952
Correspondent Contact Jiho Park
Regulation Number892.1680
Classification Product Code
KPR  
Date Received03/23/2023
Decision Date 11/02/2023
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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