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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 K874040
Device Name MAMEX DC S SL10/MG14
Applicant
Orion Corp.
P.O. Box 425
20101 Turku,  FI
Applicant Contact ENSIO KOSKENNURMI
Correspondent
Orion Corp.
P.O. Box 425
20101 Turku,  FI
Correspondent Contact ENSIO KOSKENNURMI
Regulation Number892.1710
Classification Product Code
IZH  
Date Received10/05/1987
Decision Date 11/23/1987
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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