LVivo IQS
K222970DiA Imaging Analysis Ltd · cleared 2023-02-01 · product code QIH · Radiology
Premarket evidence — what FDA accepted
source quote (p.4)
“The LVivio IQS is an extension to the LVivio Software Application (K210053), as an additional Algorithm with API that will be able to provide a Quality Score in real time to the Left 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, will be a medical device accessory.”
source quote (p.4)
“The LVivio IQS is an extension to the LVivio Software Application (K210053), as an additional Algorithm with API that will be able to provide a Quality Score in real time to the Left Ventricle from the 4 chamber apical view of the heart.”
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
Prospective clinical
n=64 patients
endpoints: 80% of the saved Exams with image quality 3-5 by visual estimation, received at least "Medium" image quality by LVivo IQS.; 90% of these cases are clinically interpretable by expert echocardiologist
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
- re_clearance
The FDA AI/ML device list shows a newer 510(k) K240769 (decision 2024-05-24) from DiA Imaging Analysis Ltd. for a matching device line ("LVivo IQS") — a new clearance for the same line is a change event.
first seen 2026-07-08 · k_number:K240769
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).