cvi42 Auto Imaging Software Application

K213998

Circle Cardiovascular Imaging Inc · cleared 2022-07-28 · product code QIH · Radiology

Premarket evidence — what FDA accepted

Device typesamd
source quote (p.5)
“cvi42 Auto is a software as a medical device (SaMD) that is intended for evaluating CT and MR images of the cardiovascular system.”
AlgorithmMachine learning techniques to aid in semi-automatic contouring of regions of interest of cardiac magnetic resonance (MR) or computed tomography (CT) images for Cardiac Function, Calcium Assessment, and Coronary Analysis.
source quote (p.5)
“cvi42 Auto uses machine learning techniques to aid in semi-automatic contouring of regions of interest of cardiac magnetic resonance (MR) or computed tomography (CT) images as follows: 1. Cardiac Function: semi-automatic contouring of the four heart chambers (including left ventricle, left atrium, right ventricle, right atrium) in MR images. 2. Calcium Assessment: using pixel intensity technique, identify calcified plaque in major coronary arteries in non-contrast enhanced CT images. 3. Coronary Analysis: semi-automatic placement of centerline in coronary vessels to visualize the coronary arteries and assess stenosis in non-contrast enhanced CT images.”
Adaptive (vs locked)No
source quote (p.5)
“None of the cases used for model validation were used for training the machine learning models.”
PCCPNo
Cybersecurity addressedYes
source quote (p.11)
“Verification and validation testing were conducted to ensure specifications and performance of the device and were performed per the FDA Guidance documents “Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" and "Content of Premarket Submission for Management of Cybersecurity in Medical Devices”.”

Validation studies (1)

Retrospective clinical

n=235 patients

endpoints: classification accuracy defined by true positives (TP), true negatives (TN), false positives (FP), and false negatives (FN); Mean volume prediction error (Mean Absolute Error, or MAE); centerline quality and performance (based on TP and FN); success rate for relevant masks

standards: ISO 13485:2016, IEC 62304:2015, ISO 14971:2019, NEMA 3.1-3.20 (2016) DICOM standards

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) K242781 (decision 2024-10-15) from Circle Cardiovascular Imaging Inc. for a matching device line ("cvi42 Software Application") — a new clearance for the same line is a change event.

    first seen 2026-07-08 · k_number:K242781

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/K213998