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510(k) Data Aggregation
K Number
K122022Device Name
ATHEROEDGE
Manufacturer
ATHEROPOINT LLC
Date Cleared
2012-09-26
(78 days)
Product Code
LLZ
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
ATHEROPOINT LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The AtheroEdge™ software is a Window's-based application program used on a personal computer for an automatic measurement of the Intima-Media Thickness (IMT) of the carotid artery from images obtained from ultrasound systems.
Device Description
AtheroEdge™ is a software package that runs on a stand-alone computer running a Microsoft Windows™ XP or Microsoft Windows™ 7.0 Operating System. There is no dedicated medical equipment required for operation of this software application except for an ultrasound machine that is the source of images of the carotid artery. These images are digitally transferred from the ultrasound machine to the computer containing the software application. AtheroEdge™ software provides a means of opening and displaying images in DICOM, ISO Joint Photographic Experts Group (JPEG) Image Compression Standard and Microsoft Windows's BMP formats. AtheroEdge™ then uses proprietary techniques and algorithms to automatically measure the Intima-Media Thickness (IMT) and its variability of the distal (far) wall of the carotid artery in ultrasound image. AtheroEdge™ software provides a means for creating a region of interest on the distal (far) wall image and display by the software. AtheroEdge™ software provides a means of analyzing the content of the image data contained within the region of interest (ROI) and compute the IMT and its variability. AtheroEdge™ can generate, view and print a report indicating what the patient's IMT and its variability values. This information is used adjunctively with other medical data by a physician to help assess the cardiovascular health of a patient. AtheroEdge™ is also capable of storing patient measurement values in the database management system along with the images for future reference.
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