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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Solid State X-Ray Imager (Flat Panel/Digital Imager)
510(k) Number K223930
Device Name A1417MCW/A1717MCW/F1417MCW
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
Wise Company, Inc.
#507, #508, 166 Gasan Digital 2-Ro
Geumcheon-Gu,  KR 08503
Correspondent Contact Sanglok Lee
Regulation Number892.1680
Classification Product Code
MQB  
Date Received12/30/2022
Decision Date 03/06/2023
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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