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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Screen, Intensifying, Radiographic
510(k) Number K974423
Device Name ULTRA-VISION MAMMOGRAPHY DETAIL, ULTRA-VISION MAMMOGRAPHY FAST DETAIL
Applicant
Sterling Diagnostic Imaging, Inc.
P.O. Box 19048
Mail Drop 102
Greenville,  SC  29602
Applicant Contact JEAN E BARLETT
Correspondent
Sterling Diagnostic Imaging, Inc.
P.O. Box 19048
Mail Drop 102
Greenville,  SC  29602
Correspondent Contact JEAN E BARLETT
Regulation Number892.1960
Classification Product Code
EAM  
Date Received11/24/1997
Decision Date 12/22/1997
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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