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510(k) K012953

GIOTTO IMAGE by Medx, Inc. — Product Code IZH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 30, 2001
Date Received
September 4, 2001
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, X-Ray, Mammographic
Device Class
Class II
Regulation Number
892.1710
Review Panel
RA
Submission Type

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