LVivo Software Application

K240553

DiA Imaging Analysis Ltd. · cleared 2024-10-04 · 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.”
AlgorithmThe LVivo platform is a software system for automated analysis of ultrasound examinations, including global and segmental evaluation of the left ventricle (LV) and right ventricular function, and bladder volume measurement. It uses automated calculation of LV size and function parameters.
source quote (p.5)
“The LVivo platform is a software system for automated analysis of ultrasound examinations. Automated analysis of echocardiographic examinations is done using DICOM movies. The LVivo platform supports global and segmental evaluation of the left ventricle (LV) of the heart. The global LV function is evaluated from two of the apical views: four-chamber (4CH) and two-chamber (2CH) by ejection fraction (EF). The segmental LV function is done from three apical views 4CH, 2CH and three chamber (3CH) and supports wall motion evaluation and strain. The LVivo platform supports also global and segmental evaluation of the LV from the parasternal Short Axis (SAX) view and the Parasternal Long Axis view (PLAX). LVivo PLAX extends the current toolbox of the LVivo platform, providing automated calculation of LV size and function parameters from the PLAX view, for cardiac function evaluation as part of the standard echocardiographic assessment in Echo environment and point-of-care. The measurements from the PLAX view add information about the contraction of the LV, its size and wall thickness and can be used for rapid evaluation of the patient's condition in the point-of-care. In addition to the LV analysis, the cardiology toolbox includes a module for automated evaluation of the Right Ventricular function and the LVivo Seamless. The LVivo platform includes one additional non-cardiac module for the measurement of the bladder volume.”
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=121 patients

endpoints: correlation vs average manual measurements of two sonographers; Specificity; Sensitivity

standards: GCP standards

Retrospective clinical

n=40 patients · 1 site(s)

endpoints: bias; limits of agreement (LOA); correlation

Reported performance (2 observations)

sensitivity0.85
source quote (p.8)
“Specificity and sensitivity using cutoff value of 28% were 85% and 85% respectively.”
specificity0.85
source quote (p.8)
“Specificity and sensitivity using cutoff value of 28% were 85% and 85% respectively.”

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
2
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

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/K240553