QuantX Breast MRI Biopsy Guidance Plugin

System, Image Processing, Radiological

Qlarity Imaging

The following data is part of a premarket notification filed by Qlarity Imaging with the FDA for Quantx Breast Mri Biopsy Guidance Plugin.

Pre-market Notification Details

Device IDK191959
501k NumberK191959
Device Name:QuantX Breast MRI Biopsy Guidance Plugin
ClassificationSystem, Image Processing, Radiological
Applicant Qlarity Imaging 222 W Merchndise Mart Plaza Suite 1230 Chicago,  IL  60654
ContactRobert Tomek
CorrespondentRobert Tomek
Qlarity Imaging 222 W Merchndise Mart Plaza Suite 1230 Chicago,  IL  60654
Product CodeLLZ  
CFR Regulation Number892.2050 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyRadiology
501k Review PanelRadiology
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-07-23
Decision Date2019-11-08

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