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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 K133972
Device Name ASPIRE CRISTALLE
Applicant
Fujifilm Medical Systems U.S.A, Inc.
419 W. Ave.
Stamford,  CT  06902
Applicant Contact PETER ALTMAN
Correspondent
Fujifilm Medical Systems U.S.A, Inc.
419 W. Ave.
Stamford,  CT  06902
Correspondent Contact PETER ALTMAN
Regulation Number892.1715
Classification Product Code
MUE  
Date Received12/26/2013
Decision Date 03/25/2014
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
Recalls CDRH Recalls
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