Imbio PHA (4.0.0)
Imbio, IncImbio PHA (4.0.0) is a medical image processing software designed to measure the maximal diameters of the heart's right and left ventricles, the main pulmonary artery, and the ascending aorta from CT pulmonary angiography scans. It uses artificial intelligence to identify and measure these structures, providing annotated images and summary reports to assist clinicians in evaluating cardiovascular health.
Intended Use
The Imbio PHA Software device is designed to measure the maximal diameters of the right and left ventricles of the heart, the main pulmonary artery, and the ascending aorta from a volumetric CTPA acquisition and report the RV/LV and Pa/Ao ratios. PHA analyzes cases using an artificial intelligence algorithm to identify the location and measurements of the anatomy. The PHA software provides the user with annotated images showing measurements. Its results are not intended to be used on a stand-alone basis for clinical decision-making or otherwise preclude clinical assessment of CTPA cases.
Technology
Imbio's PHA Software is a set of medical image post-processing computer algorithms that together perform automated right and left ventricle, pulmonary artery, and aorta measurements from CT pulmonary angiography scans. It is a single command-line executable program that outputs annotated DICOM images and a PDF report. The software uses deep learning models for segmentation and measurement, and runs on previously generated CTPA DICOM datasets integrated as part of radiological workflow.
Performance
No clinical testing was conducted. Non-clinical testing demonstrated that measurements by the PHA Software resemble those made by expert radiologists with excellent agreement (ICC=0.94). Testing included 100 contrast-enhanced CTPA datasets from multiple centers and vendors, with three expert U.S. radiologists providing ground truth for diameter measurements. The device was found to be as safe and effective as the legally marketed predicate, Imbio RV/LV (K203256).
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
6/26/2024
2 months - 2
FDA Approval
8/30/2024
Other devices from Imbio, Inc
- CAC Software2023 • 510K
- Imbio RV/LV Software2021 • 510K
- Lung Density Analysis2014 • 510K
Ready to Sharpen Your Edge?
Join hundreds of your peers who rely on RadAI Slice. Get the essential weekly briefing that empowers you to navigate the future of radiology.
We respect your privacy. Unsubscribe at any time.