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510(k) Data Aggregation
K Number
K030223Device Name
SONOCALC
Manufacturer
SONOMETRIC HEALTH, LLC
Date Cleared
2003-02-06
(15 days)
Product Code
LLZ
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
SONOMETRIC HEALTH, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The SonoCalc software is a Windows-based application program used on a personal computer for the automatic measurement of the intima media thickness of the carotid artery from images obtained from ultrasound systems.
Device Description
SonoCalc is a software package that runs on a stand-alone computer running a Microsoft Windows™ 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. SonoCalc then uses proprietary techniques and algorithms to measure the Intima-Media Thickness (IMT) of either or both of the near or far wall(s) of the carotid artery. SonoCalc can generate a report indicating what the patient's IMT value is. This information is used adjunctively with other medical data by a physician to help assess the cardiovascular health of a patient.
SonoCalc also is capable of storing patient measurement values on the hard disk along with the images for future reference.
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