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510(k) K212873

Aspire Cristalle by Fujifilm Corporation — Product Code MUE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 27, 2022
Date Received
September 9, 2021
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Full Field Digital, System, X-Ray, Mammographic
Device Class
Class II
Regulation Number
892.1715
Review Panel
RA
Submission Type

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