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510(k) K193166

MAMMOMAT Revelation by Siemens Medical Solutions USA, Inc. — Product Code MUE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 12, 2020
Date Received
November 15, 2019
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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