FDA 510(k)

DENSEEMAMMO v1.0

K-Number: K152009 · 2016-12-05

Decision Date2016-12-05

Product CodeLLZ

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

DENSEEMAMMO v1.0 is the device name listed in this FDA 510(k) record. The listed applicant is Statlife. It received FDA 510(k) clearance on 2016-12-05 under 510(k) number K152009. 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 DENSEEMAMMO v1.0?

DENSEEMAMMO v1.0 is a medical device that received FDA 510(k) clearance on 2016-12-05. The listed applicant is Statlife. The 510(k) number is K152009.

When did DENSEEMAMMO v1.0 receive FDA 510(k) clearance?

DENSEEMAMMO v1.0 received FDA 510(k) clearance on 2016-12-05, under 510(k) number K152009.

Who is the listed applicant for DENSEEMAMMO v1.0?

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

What is the FDA product code for DENSEEMAMMO v1.0?

The FDA product code for DENSEEMAMMO v1.0 is LLZ.

Other records listing Statlife 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.

K173574DenSeeMammo

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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.