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510(k) Data Aggregation
K Number
K173574Device Name
DenSeeMammo
Manufacturer
Date Cleared
2018-06-26
(218 days)
Product Code
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
Statlife
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
DenSeeMammo is a software application intended for use with Full Field Digital Mammography systems.
DenSeeMammo estimates Bl-RADS breast density category by analyzing processed digital 2D mammograms using a fully automated comparison procedure.
DenSeeMammo provides a BI-RADS breast density 5th Edition category to aid radiologists in the assessment of breast density. DenSeeMammo produces adjunctive information. It is not a diagnostic aid since the final assessment of breast density category is made by an MQSA qualified interpreting physician.
DenSeeMammo core software has been built and tested on OS X based computers.
DenSeeMammo graphical use interface software has been built and tested on Windows, OS X and Linux based computers. DenSeeMammo is compatible for images obtained from GE Senographe Essentials and Hologic Selenia Dimension systems.
Device Description
DenSeeMammo is a software application intended for use with Full Field Digital Mammography systems. DenSeeMammo estimates BI-RADS breast density category by analyzing processed digital 2D mammograms using a fully automated comparison procedure. DenSeeMammo provides a BI-RADS breast density 5th Edition category to aid radiologists in the assessment of breast density. DenSeeMammo produces adjunctive information. It is not a diagnostic aid since the final assessment of breast density category is made by an MQSA qualified interpreting physician. DenSeeMammo core software has been built and tested on OS X based computers. DenSeeMammo graphical use interface software has been built and tested on Windows, OS X and Linux based computers. DenSeeMammo v1.2 is compatible for images obtained from GE Senographe Essentials and Hologic Selenia Dimension systems.
The software use processed digital 2D mammograms in a fully automated comparison procedure that produces a BI-RADS breast density category. The software processes and analyses the image according to proprietary algorithms that allow comparison to qualified databases containing images previously visually assessed by radiologists. For each patient it provides measures of BI-RADS breast density category. DenSeeMammo provides results per patient based on the maximum density category of the two breasts.
The software works in a client-server mode and requires that the user computer be on the same local network as the server. Computations are made on the server part of the system that also provide the graphical user interface to display the results. A web browser is required to display the graphical user interface: to select the patients' images and to display the assessment of the breast density according to the BI-RADS standards and the similar images.
The software was developed using the Java-1.8 language as a 3-component web application. The software was developed following an adapted version of the model – view – controller software architectural pattern.
The device does not contact the patient, nor does it control any life-sustaining devices.
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K Number
K152009Device Name
DENSEEMAMMO v1.0
Manufacturer
Date Cleared
2016-12-05
(503 days)
Product Code
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
STATLIFE
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
DenSeeMammo is a software application intended for use with digital mammography systems. DenSeeMammo estimates BI-RADS breast density value by analyzing processed digital 2D mammograms using a fully automated comparison procedure.
DenSeeMammo provides a BI-RADS breast density 5th Edition category to aid radiologists in the assessment of breast density.
DenSeeMammo produces adjunctive information. It is not an interpretive or diagnostic aid when the final assessment of breast density category is made by an MQSA qualified interpreting physician.
DenSeeMammo core software has been built and tested on OS X based computers.
DenSeeMammo graphical use interface software has been built and tested on Windows, OS X and Linux based computers.
DenSeeMammo is compatible for images obtained from GE Senographe Essentials systems.
Device Description
DenSeeMammo analyzes processed digital 2D mammograms in a fully automated comparison procedure that produces a BI-RADS breast density value.
DenSeeMammo handles processed images extracted from DICOM files as input.
DenSeeMammo core software has been built and tested on OS X based computers.
DenSeeMammo graphical user interface software has been built and tested on Windows, OS X and Linux based computers.
DenSeeMammo software is a component which accepts digital mammography images as an input. The software processes and analyses the image according to proprietary algorithms which allow comparison to qualified databases containing images previously quoted by radiologists.
For each patient it provides measures of BI-RADS breast density category. DenSeeMammo provides results per patient based on the maximum density category of the two breasts. The patient population is symptomatic and asymptomatic women undergoing mammography. The software does perform illustrative image display but only for illustrative purposes and not for interpretation or diagnostic.
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