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U.S. Department of Health and Human Services

Medical Devices

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Parascript® AccuDetect® 6.1.0 - P120004

This is a brief overview of information related to FDA’s approval to market this product. See the links below to the Summary of Safety and Effectiveness Data (SSED) and product labeling for more complete information on this product, its indications for use, and the basis for FDA’s approval.

Product Name: Parascript® AccuDetect® 6.1.0
PMA Applicant: Parascript, LLC
Address: 6273 Monarch Park Place
Longmont, CO 80503
Approval Date: August 22, 2013
Approval Letter: http://www.accessdata.fda.gov/cdrh_docs/pdf12/P120004a.pdf

What is it? Parascript® AccuDetect® 6.1.0 is a Computer-Aided Detection (CAD) software intended to help radiologists read screening mammograms.

How does it work? Parascript® AccuDetect® 6.1.0 is a software application designed to process screening mammograms produced by Full Field Digital Mammography systems. Four view screening mammograms are automatically analyzed to mark areas consistent with breast cancer for review by a radiologist.

When is it used? Parascript® AccuDetect® 6.1.0 is intended for use in screening mammography. The radiologist is instructed to first review each case in the conventional manner and then re-examine regions marked by the AccuDetect® system before making a final assessment for the case.

What will it accomplish? In a clinical study, the addition of Parascript® AccuDetect® 6.1.0 resulted in a statistically significant increase in the effectiveness of radiologists at detecting cancer on digital mammograms.

When should it not be used? There are no known contraindications.

Additional information: The Summary of Safety and Effectiveness Data and labeling are available.