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 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 algorithm with API that provides a Quality Score in real time to the Right Ventricle from the 4-chamber apical view of the heart.
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. Essentially, the Algorithm and API, which is a module, is a medical device accessory. Algorithm AI based”
Adaptive (vs locked)FDA source did not state this
PCCPNo
Cybersecurity addressedFDA source did not state this

Validation studies (2)

Reader study (MRMC)

n=100 patients

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

Retrospective clinical

n=182 patients

endpoints: 80% of the saved Exams with image quality 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

Reported performance (1 observation)

agreement_kappaas written: “Overall agreement between LVivo IQS (RV) and quality tagging by 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

0
recalls in product code, 24mo
3
MAUDE reports in code, 12mo
—
vs code's own 3-yr baseline
0
drift signals on this device

Recall and MAUDE counts are product-code-level (reports aren't reliably attributable to one device); a recall is shown as device-attributed only when the recall record itself lists this clearance number. 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).

Applicable FDA guidance — what the submission is measured against

FDA guidance documents and guiding principles applicable to 510(k) AI/ML devices in the Radiology panel. A curated reference index, not legal or regulatory advice — each item states its own status, and a draft is never binding.

Applicability is derived from the device's FDA advisory panel and pathway — cross-cutting guidances apply to every AI/ML device; panel-specific ones are flagged. Titles, dates, and links verified against fda.gov as of July 2026.

Constat Precedent · public FDA/CMS data · descriptive decision-support, not regulatory or reimbursement advice. Share this page: constat.dev/precedent/device/K240769