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510(k) Data Aggregation
K Number
K202094Device Name
Cardiovascular Suite 4.2.1
Manufacturer
Date Cleared
2022-01-11
(532 days)
Product Code
Regulation Number
870.1425Why did this record match?
Applicant Name (Manufacturer) :
Quipu S.R.L
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Cardiovascular Suite 4.2.1 is a software program that is intended to aid trained healthcare in the quantitative analysis of vascular ultrasound images in adults, particularly for the measurement of the diameter and its changes on the brachial artery, the diameter and its changes on the carotid Intima-Media Thickness, and for carotid plaque analysis.
Device Description
The Cardiovascular Suite 4.2.1 is a software indicated for estimating early cardiovascular parameters by identifying and tracking the edges of the arteries by analyzing sequences of ultrasound images or single images of the longitudinal section of the vessel. The software consists of two main functional measurement modules: 1) the FMD-Studio for measuring Flow-Mediated-Dilation (FMD) of the brachial artery, by processing sequences of ultrasound image 2) The Carotid-Studio for measuring, by processing sequences of ultrasound images, the thickness of the carotid intima-media and the instantaneous carotid diameter that, associated with a pressure estimate, can provide arterial elasticity parameters. On single images, the software also provides a tool for Plaque Measurement and Quantification. The system is able to process previously recorded video files or directly process the video output of an ultrasound system in real time.
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