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FDA 510(k)

Mammomat Revelation

K-Number: K173408 · 2018-03-21

ApplicantSiemens Medi Cal Solutions, Inc.
Decision Date2018-03-21
Product CodeMUE
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Mammomat Revelation is the device name listed in this FDA 510(k) record. The listed applicant is Siemens Medi Cal Solutions, Inc.. It received FDA 510(k) clearance on 2018-03-21 under 510(k) number K173408. 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 Revelation?

Mammomat Revelation is a medical device that received FDA 510(k) clearance on 2018-03-21. The listed applicant is Siemens Medi Cal Solutions, Inc.. The 510(k) number is K173408.

When did Mammomat Revelation receive FDA 510(k) clearance?

Mammomat Revelation received FDA 510(k) clearance on 2018-03-21, under 510(k) number K173408.

Who is the listed applicant for Mammomat Revelation?

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

What is the FDA product code for Mammomat Revelation?

The FDA product code for Mammomat Revelation 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.

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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