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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 K212873
Device Name Aspire Cristalle
Applicant
FUJIFILM Corporation
798 Miyanodai Kaisei-Machi
Ashigarakami-Gun,  JP 258-8538
Applicant Contact Randy Vader
Correspondent
FUJIFLM Medical Systems U.S.A, Inc.
81 Hartwell Avenue, Suite 300
Lexington,  MA  02421
Correspondent Contact Jeffrey Wan
Regulation Number892.1715
Classification Product Code
MUE  
Date Received09/09/2021
Decision Date 05/27/2022
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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