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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 K954521
Device Name MAMMOSPOT PADDLE
Applicant
American Mammographics, Inc.
1302 Shawhan Ter.
Chattanooga,  TN  37411
Applicant Contact GORDON L HIXSON
Correspondent
American Mammographics, Inc.
1302 Shawhan Ter.
Chattanooga,  TN  37411
Correspondent Contact GORDON L HIXSON
Regulation Number892.1710
Classification Product Code
IZH  
Date Received09/28/1995
Decision Date 10/24/1995
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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