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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 K827489
Device Name HYPERLUX 30 IMAGE SYSTEM
Applicant
Cgr Medical Corp.
10150 Old Columbia Rd.
Columbia,  MD  21046
Applicant Contact DENNIS UPRIGHT
Correspondent
Cgr Medical Corp.
10150 Old Columbia Rd.
Columbia,  MD  21046
Correspondent Contact DENNIS UPRIGHT
Regulation Number892.1650
Classification Product Code
JAA  
Date Received11/04/1982
Decision Date 11/04/1982
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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