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510(k) K170858

FDR AQRO (DR-XD 1000) by Fujifilm Medical Systems U.S.A, Inc. — Product Code IZL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 24, 2017
Date Received
March 22, 2017
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, X-Ray, Mobile
Device Class
Class II
Regulation Number
892.1720
Review Panel
RA
Submission Type

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