cvi42 Software Application

K242781

Circle Cardiovascular Imaging Inc. · cleared 2024-10-15 · product code QIH · Radiology

Premarket evidence — what FDA accepted

Device typesamd
source quote (p.7)
“cvi42 Software Application (“cvi42”) is a software as a medical device (SaMD) that is intended for evaluating CT and MR images of the cardiovascular system.”
Algorithmsemi-automated machine learning algorithms
source quote (p.4)
“cvi42's semi-automated machine learning algorithms, included in the MR Function and CORE CT modules, are intended for an adult population.”
Adaptive (vs locked)FDA source did not state this
PCCPFDA source did not state this
Cybersecurity addressedFDA source did not state this

Validation studies (3)

Bench

sample size not stated

endpoints: tracking performance; Global Longitudinal strain; Global Circumferential strain; deformation metrics

standards: ISO 13485:2016, BS EN 62304:2006, ISO 14971:2019, DICOM standards

Retrospective clinical

n=235 patients

endpoints: classification accuracy; mean volume prediction error (MAE); centerline quality and performance; success rate for relevant masks

Retrospective clinical

n=235 patients · 9 site(s)

endpoints: performance of ML-based segmentation; mean volume prediction error (MAE); 3D Hausdorff Distance (HD); Dice coefficient; EF bias

Reported performance (3 observations)

diceas written: “LV cavity segmentation Dice coefficient”stated without value
source quote (p.19)
“a Dice coefficient above 86%”
diceas written: “RV cavity segmentation Dice coefficient”stated without value
source quote (p.19)
“a Dice coefficient above 85%”
diceas written: “LV myocardium segmentation Dice coefficient”stated without value
source quote (p.19)
“a Dice coefficient above 82%”

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) K251027 (decision 2025-10-27) from Circle Cardiovascular Imaging, Inc. for a matching device line ("cvi42 Coronary Plaque Software Application") — a new clearance for the same line is a change event.

    first seen 2026-07-08 · k_number:K251027

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/K242781