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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 K253244
Device Name AirRay-mini 80A, AirRay-mini 90A, AirRay-mini 80F, AirRay-mini 90F (AirRay-mini)
Applicant
Poskom Co., Ltd.
Poskom Tower, 227, Sowon-Ro Deogyang-Gu, Goyang-Si
Gyeonggi-Do,  KR 10534
Applicant Contact Seong Jeong Hyun
Correspondent
Poskom Co., Ltd.
Poskom Tower, 227, Sowon-Ro Deogyang-Gu, Goyang-Si
Gyeonggi-Do,  KR 10534
Correspondent Contact Seong Jeong Hyun
Regulation Number892.1720
Classification Product Code
IZL  
Date Received09/29/2025
Decision Date 02/23/2026
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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