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510(k) K103485

SENOGRAPH DS, SENOGRAPH ESSENSTIAL by General Electric Company — Product Code MUE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 6, 2011
Date Received
November 26, 2010
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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