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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 K110729
Device Name ASPIRE HD FULL-FIELD DIGITAL MAMMOGRAPHY SYSTEM
Applicant
FUJIFILM MEDICAL SYSTEMS, USA INC.
419 WEST AVENUE
STAMFORD,  CT  06902
Applicant Contact PETER ALTMAN
Correspondent
FUJIFILM MEDICAL SYSTEMS, USA INC.
419 WEST AVENUE
STAMFORD,  CT  06902
Correspondent Contact PETER ALTMAN
Regulation Number892.1715
Classification Product Code
MUE  
Date Received03/16/2011
Decision Date 09/01/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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