K-number	K191959
Device name	QuantX Breast MRI Biopsy Guidance Plugin
Applicant	Qlarity Imaging
Product code	LLZ
Device class	Class II
Decision date	Nov 8, 2019
Decision	Substantially Equivalent
Regulation	892.2050

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Source

View the full FDA submission: accessdata.fda.gov

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QuantX Breast MRI Biopsy Guidance Plugin

Everything you need for a 510(k) submission. Nothing you don't.