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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 K232753
Device Name EXPD 4343D; EXPD 3643D
Applicant
DRTECH Corporation
Suite # 1, 2 Floor/Suite # 2, 3 Floor, 29, Dunchon-Daero
541 Beon-Gil Jungwon-Gu, Seongnam-Si
Seongnam-Si,  KR 13216
Applicant Contact Kim Minjeong
Correspondent
DRTECH Corporation
Suite # 1, 2 Floor/Suite # 2, 3 Floor, 29, Dunchon-Daero
541 Beon-Gil Jungwon-Gu, Seongnam-Si
Seongnam-Si,  KR 13216
Correspondent Contact Kim Minjeong
Regulation Number892.1680
Classification Product Code
MQB  
Date Received09/08/2023
Decision Date 11/16/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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