InVision Precision LVEF (LVEF)

K232331

InVision Medical Technology Corporation · cleared 2024-04-25 · product code QIH · Radiology

FDA 510(k) summary for InVision Precision LVEF (LVEF) (K232331)

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

Premarket evidence — what FDA accepted

Device typesamd
source quote (p.4)
“InVision Precision LVEF is a software as a medical device (SaMD)”
Algorithmmachine learning algorithm
source quote (p.5)
“generates semi-automatic segmentations of the left ventricle using a machine learning algorithm”
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

sample size not stated

endpoints: Root Mean Square Deviation below a set threshold; Dice score above a set threshold

Reported performance (2 observations)

diceas written: “Dice score for A4C segmentation”0.89
source quote (p.7)
“The Dice score for A4C segmentation was 0.89”
diceas written: “Dice score for A2C segmentation”0.9
source quote (p.7)
“and for A2C segmentation was 0.90.”

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
2
drift signals on this device
  • predicate_cohort_contagion

    K232331 shares predicate K210747 with K250087 (Vscan Air), whose product code IYN recorded 85 recall event(s) in the trailing 24 months.

    first seen 2026-07-15 · predicate:K210747 sibling:K250087

  • 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/K232331