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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, X-Ray, Stationary
510(k) Number K092830
Device Name DIGITAL X-RAY IMAGING SYSTEM, MODEL DRC-1000
Applicant
VATECH Co., Ltd.
256 N. Sam Houston Pkwy. E.
Suite 115
Houston,  TX  77060
Applicant Contact VINCENT LEE
Correspondent
VATECH Co., Ltd.
256 N. Sam Houston Pkwy. E.
Suite 115
Houston,  TX  77060
Correspondent Contact VINCENT LEE
Regulation Number892.1680
Classification Product Code
KPR  
Date Received09/14/2009
Decision Date 07/21/2010
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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