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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, Mammographic
510(k) Number K872980
Device Name MAM-CP X-RAY APPARATUS
Applicant
Transworld X-Ray Corp.
P O Box 240766
Charlotte,  NC  28224
Applicant Contact LEE, JR.
Correspondent
Transworld X-Ray Corp.
P O Box 240766
Charlotte,  NC  28224
Correspondent Contact LEE, JR.
Regulation Number892.1710
Classification Product Code
IZH  
Date Received07/30/1987
Decision Date 08/27/1987
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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