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FDA 510(k)

QuantX Breast MRI Biopsy Guidance Plugin

K-Number: K191959 · 2019-11-08

ApplicantQlarity Imaging
Decision Date2019-11-08
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

QuantX Breast MRI Biopsy Guidance Plugin is a medical device manufactured by Qlarity Imaging. It received FDA 510(k) clearance on 2019-11-08 under approval number K191959. 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 QuantX Breast MRI Biopsy Guidance Plugin?

QuantX Breast MRI Biopsy Guidance Plugin is a medical device that received FDA 510(k) clearance on 2019-11-08. It is manufactured by Qlarity Imaging. The 510(k) number is K191959.

When was QuantX Breast MRI Biopsy Guidance Plugin approved by the FDA?

QuantX Breast MRI Biopsy Guidance Plugin received FDA 510(k) clearance on 2019-11-08, under approval number K191959.

What company makes QuantX Breast MRI Biopsy Guidance Plugin?

QuantX Breast MRI Biopsy Guidance Plugin is manufactured by Qlarity Imaging.

What is the FDA product code for QuantX Breast MRI Biopsy Guidance Plugin?

The FDA product code for QuantX Breast MRI Biopsy Guidance Plugin is LLZ.

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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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