Search Results
Found 1 results
510(k) Data Aggregation
K Number
K040686Device Name
M'ATH STD
Manufacturer
INTELLIGENCE IN MEDICAL TECHNOLOGIES
Date Cleared
2004-07-30
(136 days)
Product Code
LLZ
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
INTELLIGENCE IN MEDICAL TECHNOLOGIES
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
M'Ath® software is a Windows based application program running on a personal computer that is intended to aid the physician in the organisation of patient data relating to the ultrasound images or video acquired during vascular examination by sonography, and including patient characteristics. Additionally the software allows making measurements to determine the intima media thickness of the carotid artery from the accurate image and store them with the patient file.
Device Description
M'Ath®Std is a software running on a stand alone computer under Microsoft Windows operating system. Images are captured from any ultrasound device. Proprietary algorithms are used to measure Intima Media Thickness ( IMT).Storage of patient measurements values can be performed during the examination. These measurements help to detect early atherosclerosis in the carotid vascular bed.
Ask a Question
Page 1 of 1