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FDA 510(k)

MAMMOMAT B.brilliant (11372950)

K-Number: K253678 · 2026-06-18

ApplicantSiemens Medical Solutions USA, Inc.
Decision Date2026-06-18
Product CodeMUE
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

MAMMOMAT B.brilliant (11372950) 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 2026-06-18 under 510(k) number K253678. 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 B.brilliant (11372950)?

MAMMOMAT B.brilliant (11372950) is a medical device that received FDA 510(k) clearance on 2026-06-18. The listed applicant is Siemens Medical Solutions USA, Inc.. The 510(k) number is K253678.

When did MAMMOMAT B.brilliant (11372950) receive FDA 510(k) clearance?

MAMMOMAT B.brilliant (11372950) received FDA 510(k) clearance on 2026-06-18, under 510(k) number K253678.

Who is the listed applicant for MAMMOMAT B.brilliant (11372950)?

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 MAMMOMAT B.brilliant (11372950)?

The FDA product code for MAMMOMAT B.brilliant (11372950) is MUE.

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Related Devices (Code: MUE)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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