MAMMOMAT Revelation

Full Field Digital, System, X-ray, Mammographic

Siemens Medical Solutions USA, Inc.

The following data is part of a premarket notification filed by Siemens Medical Solutions Usa, Inc. with the FDA for Mammomat Revelation.

Pre-market Notification Details

Device IDK193166
510k NumberK193166
Device Name:MAMMOMAT Revelation
ClassificationFull Field Digital, System, X-ray, Mammographic
Applicant Siemens Medical Solutions USA, Inc. 40 Liberty Boulevard, 65-1A Malvern,  PA  19355
ContactMartin Rajchel
CorrespondentMartin Rajchel
Siemens Medical Solutions USA, Inc. 40 Liberty Boulevard, 65-1A Malvern,  PA  19355
Product CodeMUE  
CFR Regulation Number892.1715 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-11-15
Decision Date2020-06-12

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