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510(k) K161631

MAMMI by General Equipment For Medical Imaging — Product Code KPS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 28, 2016
Date Received
June 13, 2016
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

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

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