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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 K050866
Device Name CENTRION 500 C-ARM SYSTEM
Applicant
Osteosys Co.,Ltd
2305 Gold Mine Rd.
Brookeville,  MD  20833
Applicant Contact T. WHIT ATHEY
Correspondent
Osteosys Co.,Ltd
2305 Gold Mine Rd.
Brookeville,  MD  20833
Correspondent Contact T. WHIT ATHEY
Regulation Number892.1650
Classification Product Code
JAA  
Date Received04/05/2005
Decision Date 04/27/2005
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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