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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 K232082
Device Name EXPD 4343S
Applicant
DRTECH Corporation
Suite #1, 2 Floor / Suite #2, 3 Floor, 29,
Dunchon-Daero 541beon-Gil, Jungwon-Gu, Seongnam-Si
Gyeonggi-Do,  KR 13216
Applicant Contact Lee Juhee
Correspondent
DRTECH Corporation
Suite #1, 2 Floor / Suite #2, 3 Floor, 29,
Dunchon-Daero 541beon-Gil, Jungwon-Gu, Seongnam-Si
Gyeonggi-Do,  KR 13216
Correspondent Contact Lee Juhee
Regulation Number892.1680
Classification Product Code
MQB  
Date Received07/13/2023
Decision Date 02/13/2024
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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