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FDA 510(k)

CONTRAST ENHANCED DIGITAL MAMMOGRAPHY

K-Number: K123873 · 2013-01-29

ApplicantHologic, Inc.
Decision Date2013-01-29
Product CodeMUE
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

CONTRAST ENHANCED DIGITAL MAMMOGRAPHY is the device name listed in this FDA 510(k) record. The listed applicant is Hologic, Inc.. It received FDA 510(k) clearance on 2013-01-29 under 510(k) number K123873. 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 CONTRAST ENHANCED DIGITAL MAMMOGRAPHY?

CONTRAST ENHANCED DIGITAL MAMMOGRAPHY is a medical device that received FDA 510(k) clearance on 2013-01-29. The listed applicant is Hologic, Inc.. The 510(k) number is K123873.

When did CONTRAST ENHANCED DIGITAL MAMMOGRAPHY receive FDA 510(k) clearance?

CONTRAST ENHANCED DIGITAL MAMMOGRAPHY received FDA 510(k) clearance on 2013-01-29, under 510(k) number K123873.

Who is the listed applicant for CONTRAST ENHANCED DIGITAL MAMMOGRAPHY?

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

What is the FDA product code for CONTRAST ENHANCED DIGITAL MAMMOGRAPHY?

The FDA product code for CONTRAST ENHANCED DIGITAL MAMMOGRAPHY is MUE.

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Other records listing Hologic, Inc. as applicant

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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.

K254090I-View®Hologic, Inc.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.

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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