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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 K121674
Model FDR FS-2500. FDR MS-2000
Device Name ASPIRE HD PLUS, ASPIRE HD-S
Original Applicant
FUJIFILM MEDICAL SYSTEM U.S.A., INC.
419 west ave.
stamford,  CT  06902 6300
Original Contact peter altman
Regulation Number892.1715
Classification Product Code
MUE  
Date Received06/11/2012
Decision Date 09/21/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Radiology
Review Advisory Committee Radiology
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
Recalls CDRH Recalls
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