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 software with added support for contrast EF
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. LVivo CE-EF (Contrast EF) extends the current toolbox of the LVivo platform, by providing the ability to process Ultrasonic DICOM images which acquired by Ultrasound Equipment in which the patient was prescribed a contrast agent. In addition to the LV analysis, the cardiology toolbox includes a module for automated evaluation of the Right Ventricular function. The LVivo platform includes one additional non-cardiac module for the measurement of the bladder volume. 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: EDV 4CH correlation; ESV 4CH correlation; EF 4CH correlation; EDV 2CH correlation; ESV 2CH correlation; EF 2CH correlation; BP EDV correlation; BP ESV correlation; BP EF correlation

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

0
recalls in product code, 24mo
3
MAUDE reports in code, 12mo
—
vs code's own 3-yr baseline
1
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); 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/K243235