Aspire Cristalle

Full Field Digital, System, X-ray, Mammographic

FUJIFILM Corporation

The following data is part of a premarket notification filed by Fujifilm Corporation with the FDA for Aspire Cristalle.

Pre-market Notification Details

Device IDK212873
510k NumberK212873
Device Name:Aspire Cristalle
ClassificationFull Field Digital, System, X-ray, Mammographic
Applicant FUJIFILM Corporation 798 Miyanodai Kaisei-Machi Ashigarakami-Gun,  JP 258-8538
ContactRandy Vader
CorrespondentJeffrey Wan
FUJIFLM Medical Systems U.S.A, Inc. 81 Hartwell Avenue, Suite 300 Lexington,  MA  02421
Product CodeMUE  
CFR Regulation Number892.1715 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-09-09
Decision Date2022-05-27

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