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FDA 510(k)

DENSEEMAMMO v1.0

K-Number: K152009 · 2016-12-05

ApplicantStatlife
Decision Date2016-12-05
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

DENSEEMAMMO v1.0 is a medical device manufactured by Statlife. It received FDA 510(k) clearance on 2016-12-05 under approval 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. It is manufactured by Statlife. The 510(k) number is K152009.

When was DENSEEMAMMO v1.0 approved by the FDA?

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

What company makes DENSEEMAMMO v1.0?

DENSEEMAMMO v1.0 is manufactured by Statlife.

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

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

Other Devices by Statlife

K173574DenSeeMammo

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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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