TeraRecon Cardiovascular.Calcification.CT

K250288

Terarecon,Inc. · cleared 2025-10-23 · product code QIH · Radiology

Premarket evidence — what FDA accepted

Device typesamd
source quote (p.4)
“TeraRecon Cardiovascular.Calcification.CT is a software as a medical device (SaMD) deployed as a containerized application.”
Algorithmdeep learning based algorithms
source quote (p.6)
“The technology utilized by the subject and predicate devices to provide information for coronary artery calcification analysis is the same as both utilize deep learning based algorithms.”
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=422 patients

endpoints: Agatston classification accuracy (>= 80% with 95% CI lower bound >= 75%); Vessel calcification classification DICE similarity coefficient (>= 80% with 95% CI lower bound >= 75%)

Reported performance (2 observations)

accuracyas written: “Agatston classification accuracy”0.94CI 95% CI lower bounds above 75%
source quote (p.7)
“Furthermore, the device demonstrated robust segmentation and classification performance as indicated by Agatston categories (0-10, 11-100, 101-400, >400), with mean accuracies exceeding 94% and 95% CI lower bounds above 75%.”
diceas written: “Dice similarity coefficient”stated without valueCI lower 95% CI ≥75%
source quote (p.7)
“Segmentation performance, measured by Dice similarity coefficient against expert annotations, consistently exceeded the predefined acceptance criteria (≥80% Dice with lower 95% CI ≥75%), demonstrating reliable identification of calcified plaques across the testing population.”

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
0
drift signals on this device

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/K250288