Search Results
Found 1 results
510(k) Data Aggregation
K Number
K191959Device Name
QuantX Breast MRI Biopsy Guidance Plugin
Manufacturer
Date Cleared
2019-11-08
(108 days)
Product Code
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
Qlarity Imaging
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The QuantX Breast MRI Biopsy Guidance Plugin is a software application that assists users of the QuantX software device in planning MRI guided interventional procedures.
Device Description
The QuantX Breast MRI Biopsy Guidance Plugin assists users in planning MRI quided interventional procedures. Using information from MR images regarding the coordinates of a user-specified region of interest and fiducial coordinates, the software provides an automatic calculation of the location and depth of the targeted region of interest, such as a lesion or suspected lesion. Its primary goal is to identify where and how deep a biopsy needle should be inserted into an imaged breast in order to strike a targeted lesion or region of interest, as chosen by a trained medical professional. The QuantX Breast MRI Biopsy Guidance Plugin may be used in either the SE or Advanced version of QuantX, a software program used for the display and analysis of medical images.
Ask a Question
Ask a specific question about this device
Page 1 of 1