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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Interventional Fluoroscopic X-Ray System
510(k) Number K261413
Device Name EXTRON 3;EXTRON 6
Applicant
DRTECH Corporation
Suite #1, 2 Floor /Suite # 2, 3 Floor, 29
Dunchon-Daero 541 Beon-Gil, Jungwon-Gu
Seongnam-Si,  KR 13216
Applicant Contact Youngeun Lee
Correspondent
DRTECH Corporation
Suite #1, 2 Floor /Suite # 2, 3 Floor, 29
Dunchon-Daero 541 Beon-Gil, Jungwon-Gu
Seongnam-Si,  KR 13216
Correspondent Contact Youngeun Lee
Regulation Number892.1650
Classification Product Code
OWB  
Subsequent Product Codes
JAA   OXO  
Date Received04/30/2026
Decision Date 08/19/2026
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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