GECHO

GECHO is a software package that assists cardiologists in interpreting left ventricular function and myocardial blood flow from contrast-enhanced echocardiograms by displaying enhanced cardiac images and Time-To-Replenish parametric images. It is intended for use by cardiologists on images of adult patients who underwent contrast-enhanced echocardiography.

GECHO and its predicate (QLAB Advanced Quantification Software) are both Class II radiological image processing systems that operate on DICOM-formatted echocardiographic data. Both perform manual myocardial segmentation, automated image stabilization, automatic ECG gating, parametric imaging using (1-exp) functions, and color palette display. GECHO adds image averaging and baseline subtraction features not in the predicate, and accepts a subset of DICOM file types the predicate supports.

Not stated in this summary.

GECHO shares the same intended use, anatomical region (heart), scan type (echocardiogram), device classification (Class II), and primary technological features with the QLAB predicate. The added features (image averaging and digital subtraction) are established, well-understood noise-reduction and image processing techniques that do not raise new safety or effectiveness concerns. Software verification and validation testing confirmed design requirements were met and intended use was validated. Technical performance assessment of the Time-to-Replenish algorithm demonstrated reliable performance (RMSE 0.98 seconds, minimal bias) across representative clinical parameters, with expert survey confirmation that outputs are intuitive and useful for clinical interpretation, establishing equivalent performance and safety.