LVivo IQS

K240769

DiA Imaging Analysis Ltd. · cleared 2024-05-24 · product code QIH · Radiology

Premarket evidence — what FDA accepted

Device typesamd

source quote (p.4)

“The LVivio IQS is an extension to the LVivio IQS (K222970), as an additional Algorithm with API that will be able to provide a Quality Score in real time to the Right Ventricle from the 4-chamber apical view of the heart. In addition, the LVivo IQS will be provided as a software component to be integrated by another computer programmer into their legally marketed ultrasound imaging device. Essentially, the Algorithm and API, which is a module, is a medical device accessory.”

AlgorithmAI based

source quote (p.5)

“Algorithm AI based”

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)

Retrospective clinical

n=100 patients

endpoints: Overall agreement of 75% between the LVivo IQS results and the data tagging by experienced sonographers; The overall agreement was agreement between the LVivo IQS (RV) and quality tagging by the experienced sonographers was 77%

Prospective clinical

n=182 patients

endpoints: 80% of the saved Exams with image quality ACEP score 3-5, received at least "Medium” image quality by LVivo IQS.; 90% of these cases were clinically interpretable by the majority of three expert cardiologists specializing in echo.; In 85% of the patients with image quality 3-5 by visual estimation it was possible to obtain at least "Medium” quality score by LVivo IQS; 92% of the above saved clips were clinically interpretable

Reported performance (2 observations)

agreement_kappaas written: “Overall agreement between the LVivo IQS results and the data tagging by experienced sonographers”0.75

source quote (p.6)

“Overall agreement of 75% between the LVivo IQS results and the data tagging by experienced sonographers”

agreement_kappaas written: “Overall agreement between the LVivo IQS (RV) and quality tagging by the experienced sonographers”0.77

source quote (p.6)

“The overall agreement was agreement between the LVivo IQS (RV) and quality tagging by the experienced sonographers was 77%”

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).