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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, Mobile
510(k) Number K873982
Device Name GX-MOBILE X-RAY UNIT
Applicant
Gendex Corp.
11341 W. Melrose St.
Franklin Park,  IL  60131
Applicant Contact GERALD V LEVY
Correspondent
Gendex Corp.
11341 W. Melrose St.
Franklin Park,  IL  60131
Correspondent Contact GERALD V LEVY
Regulation Number892.1720
Classification Product Code
IZL  
Date Received09/30/1987
Decision Date 10/30/1987
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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