Caption Interpretation Automated Ejection Fraction Software

K210747

Caption Health · cleared 2022-01-19 · product code QIH · Radiology

Premarket evidence — what FDA accepted

Device typesamd

source quote (p.3)

“The Caption Interpretation Automated Ejection Fraction software is used to process previously acquired transthoracic cardiac ultrasound images, to store images, and to manipulate and make measurements on images using an ultrasound device, personal computer, or a compatible DICOM-compliant PACS system in order to provide automated estimation of left ventricular ejection fraction.”

Algorithmmachine learning-based algorithms with Simple Pooling network architecture and Linear Support Vector Machine regressor algorithm

source quote (p.5)

“The technological principle underlying both the current version of Caption Interpretation Automated Ejection Fraction Software and the predicate device remains the same, in that both the subject device and predicate enable the calculation of ejection fraction (EF) on previously acquired cardiac scans using machine learning-based algorithms and biplane apical echocardiographic images.”

Adaptive (vs locked)FDA source did not state this

PCCPFDA source did not state this

Cybersecurity addressedFDA source did not state this

Validation studies (2)

Bench

sample size not stated

Retrospective clinical

n=186 cases

endpoints: root mean square deviation

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).