MAMMOMAT Revelation
K-Number: K193166 · 2020-06-12
ApplicantSiemens Medical Solutions USA, Inc.
Decision Date2020-06-12
Product CodeMUE
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
MAMMOMAT Revelation is a medical device manufactured by Siemens Medical Solutions USA, Inc.. It received FDA 510(k) clearance on 2020-06-12 under approval number K193166. 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 2020-06-12. It is manufactured by Siemens Medical Solutions USA, Inc.. The 510(k) number is K193166.
When was MAMMOMAT Revelation approved by the FDA?
MAMMOMAT Revelation received FDA 510(k) clearance on 2020-06-12, under approval number K193166.
What company makes MAMMOMAT Revelation?
MAMMOMAT Revelation is manufactured by Siemens Medical Solutions USA, Inc..
What is the FDA product code for MAMMOMAT Revelation?
The FDA product code for MAMMOMAT Revelation is MUE.
Other Devices by Siemens Medical Solutions USA, Inc.
Related Devices (Code: MUE)
Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.