MAMMOVISTA B.smart
K-Number: K212621 · 2021-11-12
ApplicantSiemens Medical Solutions USA, Inc.
Decision Date2021-11-12
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
MAMMOVISTA B.smart is a medical device manufactured by Siemens Medical Solutions USA, Inc.. It received FDA 510(k) clearance on 2021-11-12 under approval number K212621. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the MAMMOVISTA B.smart?
MAMMOVISTA B.smart is a medical device that received FDA 510(k) clearance on 2021-11-12. It is manufactured by Siemens Medical Solutions USA, Inc.. The 510(k) number is K212621.
When was MAMMOVISTA B.smart approved by the FDA?
MAMMOVISTA B.smart received FDA 510(k) clearance on 2021-11-12, under approval number K212621.
What company makes MAMMOVISTA B.smart?
MAMMOVISTA B.smart is manufactured by Siemens Medical Solutions USA, Inc..
What is the FDA product code for MAMMOVISTA B.smart?
The FDA product code for MAMMOVISTA B.smart is LLZ.
Other Devices by Siemens Medical Solutions USA, Inc.
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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.