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510(k) K200424

Giotto Class (Models - 3000X-YY and 4000X-YY) by Ims Giotto S.P.A. — Product Code MUE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 18, 2020
Date Received
February 20, 2020
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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