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FDA 510(k)

M-VU BREAST DENSITY

K-Number: K132742 · 2013-12-03

ApplicantVucomp, Inc.
Decision Date2013-12-03
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

M-VU BREAST DENSITY is the device name listed in this FDA 510(k) record. The listed applicant is Vucomp, Inc.. It received FDA 510(k) clearance on 2013-12-03 under 510(k) number K132742. 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 M-VU BREAST DENSITY?

M-VU BREAST DENSITY is a medical device that received FDA 510(k) clearance on 2013-12-03. The listed applicant is Vucomp, Inc.. The 510(k) number is K132742.

When did M-VU BREAST DENSITY receive FDA 510(k) clearance?

M-VU BREAST DENSITY received FDA 510(k) clearance on 2013-12-03, under 510(k) number K132742.

Who is the listed applicant for M-VU BREAST DENSITY?

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

What is the FDA product code for M-VU BREAST DENSITY?

The FDA product code for M-VU BREAST DENSITY is LLZ.

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Other records listing Vucomp, 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.

K061160M-VU CAD STATIONK060451M-VU VIEWER STATION

Related Devices (Code: LLZ)

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

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

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