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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 K905748
Device Name MAMEX DC AMI SL12/MG15
Applicant
Soredex, Inc.
Nilsiankatu 10-14
P.O. Box 79
Sf-00511 Helsinki Finland,  FI
Applicant Contact ENSIO KOSKENNURMI
Correspondent
Soredex, Inc.
Nilsiankatu 10-14
P.O. Box 79
Sf-00511 Helsinki Finland,  FI
Correspondent Contact ENSIO KOSKENNURMI
Regulation Number892.1710
Classification Product Code
IZH  
Date Received12/26/1990
Decision Date 03/07/1991
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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