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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Image Processing, Radiological
510(k) Number K152172
Device Name Econsole1
Applicant
DRTECH Corporation
Suite #2, 3 Floor, 29, Dunchon-Daero541beon-Gil,
Jungwon-Gu
Seongnam-Si,  KR 462-807
Applicant Contact CHOUL-WOO SHIN
Correspondent
DRTECH Corporation
Suite #2, 3 Floor, 29, Dunchon-Daero541beon-Gil,
Jungwon-Gu
Seongnam-Si,  KR 462-807
Correspondent Contact CHOUL-WOO SHIN
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received08/04/2015
Decision Date 12/14/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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