LVivo IQS

K222970

DiA Imaging Analysis Ltd · cleared 2023-02-01 · product code QIH · Radiology

FDA 510(k) summary for LVivo IQS (K222970)

Constat organizes this clearance into predicate context, validation evidence, reported performance, postmarket signals, and reimbursement links. Each extracted claim stays tied to the public FDA source; missing fields remain explicitly unstated.

Validation studies
2
Cited predicates
1
Performance observations
0
Product code
QIH
Official FDA 510(k) database record ↗FDA 510(k) source PDF ↗

Premarket evidence — what FDA accepted

Device typesamd
source quote (p.3)
“LVivo platform is intended for non-invasive processing of ultrasound images to detect, measure, and calculate relevant medical parameters of structures and function of patients with suspected disease. In addition, it has the ability to provide Quality Score feedback. ... The LVivo IQS will be provided as a software component to be integrated by another computer programmer into their legally marketed ultrasound imaging device.”
AlgorithmAlgorithm with API
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.”
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=100 patients

endpoints: Overall agreement of 75% between the LVivo IQS results and the data tagging by experienced sonographer.

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

1
recalls in product code, 24mo
4
MAUDE reports in code, 12mo
—
vs code's own 3-yr baseline
3
drift signals on this device
  • predicate_cohort_contagion

    K222970 shares predicate K210053 with K232500 (Lumify Diagnostic Ultrasound System), whose product code IYN recorded 85 recall event(s) in the trailing 24 months.

    first seen 2026-07-15 · predicate:K210053 sibling:K232500

  • 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_reason_pattern

    Software/algorithm-related recall in product code QIH (PIE Medical Imaging B.V., initiated 2026-05-07): "User measurement value reported by diagnostic bioimaging software intended to measure/visualize cardiovascular structures may be larger (0.8% to 34.4%) than the actual anatomical d" Recalling firm is another firm in the same product code.

    first seen 2026-08-26 · recall res_event_number:98930

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 2026-08-26.

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.

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Constat Precedent · public FDA/CMS data · descriptive decision-support, not regulatory or reimbursement advice. Share this page: constat.dev/precedent/device/K222970