Cardiac CT Function Software Application

K241038

Circle Cardiovascular Imaging · cleared 2024-06-07 · product code QIH · Radiology

Premarket evidence — what FDA accepted

Device typesamd

source quote (p.5)

“Circle's Cardiac CT Function Software Application (“CT Function Module” or “CT Function", for short) is a software device that enables the analysis of cardiac images acquired using computed tomography (CT) scanners. ... biological characteristics are not applicable since both the subject device and predicate device are software as a medical device applications with no tangible component interfacing with the body.”

AlgorithmArtificial Intelligence / Machine Learning (AI/ML) algorithm to detect and segment heart structures and post-processing methods; Semi-automatic determination of epicardial and endocardial contours, via segmentation of the LV cavity, LV myocardium, and RV cavity in the ED and ES phases using Machine Learning techniques.

source quote (p.5)

“The CT Function Module implements an Artificial Intelligence / Machine Learning (AI/ML) algorithm to detect and segment heart structures and post-processing methods to convert the heart segments to editable surfaces. ... Semi-automatic determination of epicardial and endocardial contours, via segmentation of the LV cavity, LV myocardium, and RV cavity in the ED and ES phases using Machine Learning techniques.”

Adaptive (vs locked)FDA source did not state this

PCCPNo

Cybersecurity addressedNo

Validation studies (1)

Retrospective clinical

n=9 sites · 9 site(s)

endpoints: mean volume prediction error (Mean Absolute Error in predicted volumetric measures, or MAE); 3D Hausdorff Distance (HD); Dice coefficient; EF bias

standards: ISO 13485:2016, IEC 62304:2015, ISO 14971:2019, DICOM standards

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

recalls in product code, 24mo

MAUDE reports in code, 12mo

—

vs code's own 3-yr baseline

drift signals on this device

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).