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510(k) K173132

ASPIRE Cristalle by Fujifilm Medical Systems U.S.A, Inc. — Product Code MUE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 27, 2017
Date Received
September 29, 2017
Clearance Type
Special
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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  • K170451 — FDX Console (DR-ID300CL) Software (March 16, 2017)

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