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FDA 510(k)

Mammomat Revelation

K-Number: K173408 · 2018-03-21

Decision Date2018-03-21
Product CodeMUE
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Mammomat Revelation is a medical device manufactured by Siemens Medi Cal Solutions, Inc.. It received FDA 510(k) clearance on 2018-03-21 under approval number K173408. The device is classified under product code MUE. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Mammomat Revelation?

Mammomat Revelation is a medical device that received FDA 510(k) clearance on 2018-03-21. It is manufactured by Siemens Medi Cal Solutions, Inc.. The 510(k) number is K173408.

When was Mammomat Revelation approved by the FDA?

Mammomat Revelation received FDA 510(k) clearance on 2018-03-21, under approval number K173408.

What company makes Mammomat Revelation?

Mammomat Revelation is manufactured by Siemens Medi Cal Solutions, Inc..

What is the FDA product code for Mammomat Revelation?

The FDA product code for Mammomat Revelation is MUE.

Other Devices by Siemens Medi Cal Solutions, Inc.

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Related Devices (Code: MUE)

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.