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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 K904517
Device Name MAMMOSPOT 3 AND MAMMOSPOT 8
Applicant
American Mammographics, Inc.
1302 Shawhan Ter.
Chattanooga,  TN  37411
Applicant Contact GORDON HIXSON
Correspondent
American Mammographics, Inc.
1302 Shawhan Ter.
Chattanooga,  TN  37411
Correspondent Contact GORDON HIXSON
Regulation Number892.1710
Classification Product Code
IZH  
Date Received10/03/1990
Decision Date 11/15/1990
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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