QLAB Advanced Quantification Software
Philips HealthcareQLAB Advanced Quantification Software is a tool designed to help clinicians view and measure ultrasound images, specifically focusing on analyzing the heart's right ventricle using advanced automatic segmentation and machine learning. It assists healthcare professionals by providing accurate measurements that improve cardiac assessments without manual contouring for most cases, making the diagnostic process faster and more reliable.
Intended Use
QLAB Advanced Quantification Software is a software application package. It is designed to view and quantify image data acquired on Philips ultrasound systems.
Technology
Integrates automatic segmentation technology (from HeartModel) and TomTec-Arena 4D RV-function using machine learning algorithms to delineate the right ventricle endocardial contours semi-automatically with user edit capability.
Performance
Verification and software validation activities were conducted including Machine Learning Algorithm Training and a Validation Study showing end diastolic volume errors below 15%. A published external study confirms high accuracy and reproducibility compared to cardiac MRI, with minor revisions needed in most cases and no clinical testing required for clearance.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
6/20/2019
6 months - 2
FDA Approval
12/20/2019
Other devices from Philips Healthcare
- QLAB Advanced Quantification Software2020 • 510K
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