LVivo Software Application

K210053

DiA Imaging Analysis Ltd · cleared 2021-02-05 · product code QIH · Radiology

Premarket evidence — what FDA accepted

Device typesamd

source quote (p.4)

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

Algorithmneural network

source quote (p.7)

“The Intended Use and the technological characteristics in the current device are the same as those in the predicate device, including the addition of the neural network, do not affect the safety and effectiveness of the device.”

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=100 patients

endpoints: biplane EF correlation; specificity; sensitivity; kappa; GLS acceptance criteria: cutoff value < -17; SWM acceptance criteria: Sensitivity >=75%

standards: GCP standards

Reported performance (2 observations)

sensitivity0.75

source quote (p.7)

“For GLS acceptance criteria: cutoff value < -17, Sensitivity>=75% compared to ref WSMI, similar or better results compared to subject device For SWM acceptance criteria: Sensitivity >=75%, similar or better results compared to subject device”

agreement_kappaas written: “kappa”stated without value

source quote (p.7)

“Acceptance criteria for EF analysis: biplane EF correlation >=80%, similar or better EF biplane results in terms of correlation, specificity, sensitivity, and kappa with respect to subject device.”

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
re_clearance
The FDA AI/ML device list shows a newer 510(k) K243235 (decision 2025-03-03) 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:K243235
re_clearance
The FDA AI/ML device list shows a newer 510(k) K240553 (decision 2024-10-04) 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:K240553

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).