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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 K193017
Device Name EVS 4343W / EVS 4343WG / EVS 4343WP / EVS 3643W / EVS 3643WG / EVS 3643WP
Applicant
DRTECH Corporation
Suite #1, 1 Floor / Suite #2, 3 Floor, 29,
Dunchon-Daero541 Beon-Gil
Jungwon-Gu, Seongam-Si,  KR 13216
Applicant Contact Shin Dongwook
Correspondent
DRTECH Corporation
Suite #1, 1 Floor / Suite #2, 3 Floor, 29,
Dunchon-Daero541 Beon-Gil
Jungwon-Gu, Seongam-Si,  KR 13216
Correspondent Contact Shin Dongwook
Regulation Number892.1680
Classification Product Code
MQB  
Date Received10/29/2019
Decision Date 11/22/2019
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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