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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name full field digital, system, x-ray, mammographic
510(k) Number K120246
Device Name KODAK DIRECTVIEW CR MAMMOGRAPHY SYSTEM (USING CARESTREAM CR MAMMOGRAPHY CASSETTE WITH SNP-M1 SCREEN)
Applicant
CARESTREAM HEALTH,INC.
150 VERONA STREET
ROCHESTER,  NY  14608
Applicant Contact KATHERINE HONSINGER
Correspondent
CARESTREAM HEALTH,INC.
150 VERONA STREET
ROCHESTER,  NY  14608
Correspondent Contact KATHERINE HONSINGER
Regulation Number892.1715
Classification Product Code
MUE  
Date Received01/27/2012
Decision Date 08/28/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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