Mammomat Fusion with Stereotactic Biopsy
K-Number: K163252 · 2017-01-10
ApplicantSiemens Medical Solutions USA, Inc.
Decision Date2017-01-10
Product CodeMUE
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
Mammomat Fusion with Stereotactic Biopsy is a medical device manufactured by Siemens Medical Solutions USA, Inc.. It received FDA 510(k) clearance on 2017-01-10 under approval number K163252. 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 Fusion with Stereotactic Biopsy?
Mammomat Fusion with Stereotactic Biopsy is a medical device that received FDA 510(k) clearance on 2017-01-10. It is manufactured by Siemens Medical Solutions USA, Inc.. The 510(k) number is K163252.
When was Mammomat Fusion with Stereotactic Biopsy approved by the FDA?
Mammomat Fusion with Stereotactic Biopsy received FDA 510(k) clearance on 2017-01-10, under approval number K163252.
What company makes Mammomat Fusion with Stereotactic Biopsy?
Mammomat Fusion with Stereotactic Biopsy is manufactured by Siemens Medical Solutions USA, Inc..
What is the FDA product code for Mammomat Fusion with Stereotactic Biopsy?
The FDA product code for Mammomat Fusion with Stereotactic Biopsy is MUE.
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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.