FDA 510(k)

DenSeeMammo

K-Number: K173574 · 2018-06-26

Decision Date2018-06-26

Product CodeLLZ

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

DenSeeMammo is the device name listed in this FDA 510(k) record. The listed applicant is Statlife. It received FDA 510(k) clearance on 2018-06-26 under 510(k) number K173574. 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?

DenSeeMammo is a medical device that received FDA 510(k) clearance on 2018-06-26. The listed applicant is Statlife. The 510(k) number is K173574.

When did DenSeeMammo receive FDA 510(k) clearance?

DenSeeMammo received FDA 510(k) clearance on 2018-06-26, under 510(k) number K173574.

Who is the listed applicant for DenSeeMammo?

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?

The FDA product code for DenSeeMammo 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.

K152009DENSEEMAMMO v1.0

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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.