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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 K251223
Device Name HnX-P1, HnX-PB
Applicant
H&abyz Co., Ltd.
1f, 2-Dong, 41-16 Cheoinseong-Ro, Namsa-Myeon, Cheoin-Gu
Yongin-Si,  KR 17118
Applicant Contact Jimin Han
Correspondent
H&abyz Co., Ltd.
1f, 2-Dong, 41-16 Cheoinseong-Ro, Namsa-Myeon, Cheoin-Gu
Yongin-Si,  KR 17118
Correspondent Contact Jimin Han
Regulation Number892.1720
Classification Product Code
IZL  
Date Received04/21/2025
Decision Date 08/04/2025
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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