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FDA 510(k)

MAMMOMAT B.brilliant

K-Number: K233539 · 2024-03-27

ApplicantSiemens Medical Solutions USA, Inc.
Decision Date2024-03-27
Product CodeMUE
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

MAMMOMAT B.brilliant 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 2024-03-27 under 510(k) number K233539. 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?

MAMMOMAT B.brilliant is a medical device that received FDA 510(k) clearance on 2024-03-27. The listed applicant is Siemens Medical Solutions USA, Inc.. The 510(k) number is K233539.

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

MAMMOMAT B.brilliant received FDA 510(k) clearance on 2024-03-27, under 510(k) number K233539.

Who is the listed applicant for MAMMOMAT B.brilliant?

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?

The FDA product code for MAMMOMAT B.brilliant is MUE.

Other records listing Siemens Medical Solutions USA, Inc. as applicant

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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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.

K253678MAMMOMAT B.brilliant (11372950)Siemens Medical Solutions USA, Inc.K254092Bellalun 2D (VDMS-1000S)Vieworks Co., Ltd.K260087Senographe Pristina; SenoBright HD; Pristina Serena; Pristina Serena BrightGE Medical Systems SCSK243420HESTIAGenoray Co., Ltd.K2438492430TCA with Xmaru WRayence Co., Ltd.K241113VIVIX-MVieworks Co., Ltd.

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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