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510(k) Data Aggregation
K Number
K201250Device Name
SQuEEZ Software
Manufacturer
Date Cleared
2020-12-18
(221 days)
Product Code
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
Cardiowise, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The SQuEEZ Software is an image analysis software application for cardiac Computer Tomography (CT) studies to assist cardiologists and radiologists in assessing function when producing a cardiac evaluation. The software calculates a Stretch Quantifier for Endocardial Engraved Zones (SQuEEZ) value to highlight and color code the wall motions of the heart. Tools are provided to display regional motion properties of the heart.
Device Description
Cardiowise SQuEEZ Software is a post processing image analysis software application for cardiac Computer Tomography (CT) studies to assist cardiologists and radiologists in assessing left ventricle function when producing a cardiac evaluation. SQuEEZ Software enables a quantitative evaluation of the regional myocardial strain using the data from an ultra-high-resolution cardiac CT scan that requires an acquisition time of as short as a single heartbeat. This is done by calculating a Stretch Quantifier for Endocardial Engraved Zones (SQuEEZ) value to highlight and color code the wall motions of the heart. The resulting analysis is graphically presented in threedimensional color contour maps or regional graphical representations that indicate the level of strain the left ventricle experiences during the cardiac cycle.
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