EchoMeasure
K241430iCardio.ai · cleared 2024-10-10 · product code QIH · Radiology
Premarket evidence — what FDA accepted
source quote (p.4)
“iCardio.ai EchoMeasure is software that is used to process previously acquired DICOM-compliant cardiac ultrasound images, and to make measurements on these images in order to provide automated estimation of several cardiac measurements.”
source quote (p.6)
“Machine learning based view detection, quality grading, key frame selection, automated keypoint detection and segmentation form the basis of the software's automated analysis.”
Validation studies (1)
Retrospective clinical
n=200 patients · 2 site(s)
endpoints: Aortic Annulus Diameter; Left Ventricular Outflow Tract Diameter; Sinus of Valsalva Diameter; Sinotubular Junction Diameter; Left Atrial Diameter; Left Ventricular Diameter (Systole); Left Ventricular Diameter (Diastole); Right Ventricular Diameter (Diastole); Interventricular Septal Thickness; Posterior Thickness; Left Ventricular Volume (A4C-Systole); Left Ventricular Volume (A4C-Diastole); Left Ventricular Volume (A2C-Systole); Left Ventricular Volume (A2C-Diastole); Biplane Left Ventricular Volume (Systole); Biplane Left Ventricular Volume (Diastole)
Reported performance (0 observations)
FDA source did not state a quantitative performance metric — non-reporting is itself the signal.
Each value carries its own analysis unit and task — never compare or pool across devices. Source: 510(k) summary PDF.
Predicate network
Postmarket — what happened after clearance
Recall and MAUDE counts are product-code-level (reports aren't reliably attributable to one device). Signals are descriptive observables with sources — never a judgment that the device is unsafe or drifting. Snapshot 2026-07-08.
Reimbursement — how devices like this got paid
Not yet tracked — no payment pathway indexed for this clearance (the reimbursement corpus is a growing seed set).