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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 K960381
Device Name MAM-CH22S WITH AUTOMATIC FILTER SELECTION OPTION
Applicant
Elscint, Inc.
505 Main St.
Suite 300
Hackensack,  NJ  07601
Applicant Contact THOMAS J SPACKMAN, M.D., F.A.C.R.
Correspondent
Elscint, Inc.
505 Main St.
Suite 300
Hackensack,  NJ  07601
Correspondent Contact THOMAS J SPACKMAN, M.D., F.A.C.R.
Regulation Number892.1710
Classification Product Code
IZH  
Date Received01/26/1996
Decision Date 04/29/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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