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510(k) K111434

GIOTTO IMAGE 3D, GIOTTO IMAGE 3D-L by Giotto USA, LLC — Product Code MUE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 27, 2011
Date Received
May 23, 2011
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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