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510(k) K140996

MAMMI by General Equipment For Medical Imaging (Oncovision- — Product Code KPS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 11, 2014
Date Received
April 17, 2014
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

Device Name
System, Tomography, Computed, Emission
Device Class
Class II
Regulation Number
892.1200
Review Panel
RA
Submission Type

Other clearances by General Equipment For Medical Imaging (Oncovision-

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