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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 No. 1, 2 Floor/Suite No.2, 3 Floor, 29, Dunchon-Daero
541beon-gil Jungwon-gu, Seongnam-si
Gyeonggi-do,  KR 13216
Applicant Contact Lee Juhee
Correspondent
DRTECH Corporation
Suite No. 1, 2 Floor/Suite No.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
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