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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 K171137
Device Name EVS 2430W, EVS 2430GW
Applicant
Drtech Corporation
Suite # 2, 3 Floor, 29
Dunchon-Daero541 Beon-Gil, Jungwon-Gu
Seongnam-Si,  KR 13230
Applicant Contact Choul-Woo Shin
Correspondent
Drtech Corporation
Suite # 2, 3 Floor, 29
Dunchon-Daero541 Beon-Gil, Jungwon-Gu
Seongnam-Si,  KR 13230
Correspondent Contact Choul-Woo Shin
Regulation Number892.1680
Classification Product Code
MQB  
Date Received04/17/2017
Decision Date 05/15/2017
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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