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FDA 510(k)

MAMMOVISTA B.smart (VB70)

K-Number: K223363 · 2023-01-12

ApplicantSiemens Medical Solutions USA, Inc.
Decision Date2023-01-12
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

MAMMOVISTA B.smart (VB70) is the device name listed in this FDA 510(k) record. The listed applicant is Siemens Medical Solutions USA, Inc.. It received FDA 510(k) clearance on 2023-01-12 under 510(k) 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. The listed applicant is Siemens Medical Solutions USA, Inc.. The 510(k) number is K223363.

When did MAMMOVISTA B.smart (VB70) receive FDA 510(k) clearance?

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

Who is the listed applicant for MAMMOVISTA B.smart (VB70)?

The FDA 510(k) record lists Siemens Medical Solutions USA, Inc. as the applicant. This does not by itself establish the device manufacturer.

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

View on FDA Database →

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

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