QLAB Advanced Quantification Software
Philips HealthcareQLAB Advanced Quantification Software is a software application that assists clinicians by providing advanced tools to view and quantify ultrasound image data, specifically for cardiac assessment including mitral valve quantification, helping improve diagnosis and treatment planning.
Intended Use
QLAB Advanced Quantification Software is a software application package designed to view and quantify image data acquired on Philips ultrasound systems.
Technology
The software integrates machine-learning-derived semi-automatic 3D segmentation technology of the heart chambers and mitral valve (3D Auto MV application), combining Philips HeartModel segmentation with TomTec-Arena 4D MV Assessment to provide a dynamic clinical quantification tool. The 3D surface model is generated automatically with user ability to edit landmarks.
Performance
Verification and software validation testing including algorithm training and validation were performed to support safe and effective performance. No clinical data were needed for substantial equivalence determination. Testing demonstrated conformance to standards and successful function of the new 3D Auto MV application within QLAB 15.0 suite.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
4/13/2020
1 month - 2
FDA Approval
6/3/2020
Other devices from Philips Healthcare
- QLAB Advanced Quantification Software2019 • 510K
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