LVivo Software Application

K243235

DiA Imaging Analysis Ltd. · cleared 2025-03-03 · product code QIH · Radiology

Premarket evidence — what FDA accepted

Device typesamd

source quote (p.5)

“The LVivo platform is a software system for automated analysis of ultrasound examinations.”

Algorithmautomated analysis of ultrasound examinations with added support for Contrast EF

source quote (p.5)

“The LVivo platform is a software system for automated analysis of ultrasound examinations. Algorithm Added Support for Contrast EF”

Adaptive (vs locked)FDA source did not state this

PCCPFDA source did not state this

Cybersecurity addressedFDA source did not state this

Validation studies (1)

Retrospective clinical

n=101 patients · 4 site(s)

endpoints: Comparison of automated and manual measurements for EDV; Comparison of automated and manual measurements for ESV; Comparison of automated and manual measurements for EF

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

re_clearance
The FDA AI/ML device list shows a newer 510(k) K243862 (decision 2025-03-17) from DiA Imaging Analysis Ltd. for a matching device line ("LVivo Software Application") — a new clearance for the same line is a change event.
first seen 2026-07-08 · k_number:K243862

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).