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FDA 510(k)

MAMMOVISTA B.smart (VB70)

K-Number: K223363 · 2023-01-12

Decision Date2023-01-12
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

MAMMOVISTA B.smart (VB70) is a medical device manufactured by Siemens Medical Solutions USA, Inc.. It received FDA 510(k) clearance on 2023-01-12 under approval number K223363. 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 (VB70)?

MAMMOVISTA B.smart (VB70) is a medical device that received FDA 510(k) clearance on 2023-01-12. It is manufactured by Siemens Medical Solutions USA, Inc.. The 510(k) number is K223363.

When was MAMMOVISTA B.smart (VB70) approved by the FDA?

MAMMOVISTA B.smart (VB70) received FDA 510(k) clearance on 2023-01-12, under approval number K223363.

What company makes MAMMOVISTA B.smart (VB70)?

MAMMOVISTA B.smart (VB70) is manufactured by Siemens Medical Solutions USA, Inc..

What is the FDA product code for MAMMOVISTA B.smart (VB70)?

The FDA product code for MAMMOVISTA B.smart (VB70) is LLZ.

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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.