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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 K242770
Device Name EXPD 114; EXPD 114G; EXPD 114P; EXPD 114PG
Applicant
DRTECH Corporation
Suite # 1, 2 Floor/Suite # 2, 3 Floor
29, Dunchon-Daero 541beon-Gil
Jungwon-Gu, Seongnam-Si,  KR 13216
Applicant Contact YeongSuk An
Correspondent
DRTECH Corporation
Suite # 1, 2 Floor/Suite # 2, 3 Floor
29, Dunchon-Daero 541beon-Gil
Jungwon-Gu, Seongnam-Si,  KR 13216
Correspondent Contact YeongSuk An
Regulation Number892.1680
Classification Product Code
MQB  
Date Received09/13/2024
Decision Date 03/20/2025
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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