Philips Azurion - 10 2 D Quantitative Analysis (Option); 10.1 Intended Use of 2 D Quantitative Analysis

10 2D Quant
ave Analysis (Opon)
The informaon in this secon applies to 2D Quantave Analysis Release 1.0.
2D Quantave Analysis is a dedicated suite of analysis applicaons that allow you to obtain
quantave informaon about coronary arteries, peripheral arteries, and ventricles.
10.1 Intended Use of 2D Quantave Analysis
Device Descripon
“2D Quantave Analysis” (2D-QA) is a soware device that assists the user with quancaon of
• vessels and vessel obstrucons,
• ventricular volumes and
• ventricular wall moon
from angiographic X-ray images. The soware provides semi-automac contour detecon of vessels,
catheters and the le ventricle in angiographic X-ray images. 2D-QA implements computaonal models
for the quancaon of vessels, obstrucons in vessels, ventricular volumes and ventricular local wall
moon from 2D contours.
Medical Purpose
“2D Quantave Analysis” (2D-QA) is a post processing soware medical device intended to assist
physicians through providing quantave informaon as addional input for their comprehensive
diagnosis decision making process and planning during cardiovascular procedures and for post
procedural evaluaon. 2D-QA consists of six applicaons:
The “2D Quantave Coronary Analysis” applicaon is intended to be used for quancaon of
coronary artery dimensions (approximately 1 to 6 mm) from 2D angiographic images.
The “2D Quantave Vascular Analysis” applicaon is intended to be used for quancaon of aorc
and peripheral artery dimensions (approximately 5 to 50 mm) from 2D angiographic images.
The “2D Le Ventricle Analysis” and the “Biplane 2D Le Ventricle Analysis” applicaons are intended
to be used for quancaon of le ventricular volumes and local wall moon from monoplane and
from biplane angiographic series, respecvely.
The “2D Right Ventricle Analysis” and the “Biplane 2D Right Ventricle Analysis” applicaons are
intended to be used for quancaon of right ventricular volumes and local wall moon from
monoplane and from biplane angiographic series, respecvely.
Paent Populaon
The “2D Quantave Analysis” soware device is suitable for paents with a (suspected) cardiovascular
disease who undergo an angiographic cardiovascular procedure.
Intended Operator Prole
The “2D Quantave Analysis” device is intended to be used and operated by or under supervision of a
physician who is fully skilled and responsible for sound clinical judgment, and for applying the best
clinical procedure.
Contact with body part / ssue type
“2D Quantave Analysis” is a soware medical device and does not come in contact with the paent.
2D Quantave Analysis (Opon) Intended Use of 2D Quantave Analysis
Azurion Release 1.2 Ins
trucons for Use 156 Philips Healthcare 4522 203 52421