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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 K173132
Device Name ASPIRE Cristalle
Applicant
Fujifilm Medical Systems U.S.A, Inc.
419 W. Ave.
Stamford,  CT  06902
Applicant Contact Jyh-Shyan Lin
Correspondent
Fujifilm Medical Systems U.S.A, Inc.
419 W. Ave.
Stamford,  CT  06902
Correspondent Contact Jyh-Shyan Lin
Regulation Number892.1715
Classification Product Code
MUE  
Date Received09/29/2017
Decision Date 10/27/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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