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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, Mobile
510(k) Number K250976
Device Name Airbile-100
Applicant
Poskom Co., Ltd.
Poskom Tower, 227, Sowon-Ro Deogyang-Gu, Goyang-Si Gyeonggi
Gyeonggi-Do,  KR 10534
Applicant Contact Seong Jeong Hyun
Correspondent
GMSC Co., Ltd.
B 612, 66, Cheongcho-Ro, Deokyang-Gu, Goyang-Si
Gyeonggi-Do,  KR 10543
Correspondent Contact Jonghyeon Kim
Regulation Number892.1720
Classification Product Code
IZL  
Date Received03/31/2025
Decision Date 12/19/2025
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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