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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, Fluoroscopic, Image-Intensified
510(k) Number K132289
Device Name GEMSS MEDICAL SYSTEMS SURGICAL MOBILE FLUOROSCOPIC X-RAY SYSTEM
Applicant
Gemss Medical Systems Co., Ltd.
11874 S. Evelyn Cir.
Houston,  TX  77071
Applicant Contact HARVEY KNAUSS
Correspondent
Gemss Medical Systems Co., Ltd.
11874 S. Evelyn Cir.
Houston,  TX  77071
Correspondent Contact HARVEY KNAUSS
Regulation Number892.1650
Classification Product Code
JAA  
Subsequent Product Code
OXO  
Date Received07/23/2013
Decision Date 06/16/2014
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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