TeraRecon Cardiovascular.Calcification.CT
K250288Terarecon,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; Vessel calcification classification DICE similarity coefficient
Reported performance (2 observations)
diceas written: “Dice similarity coefficient (segmentation)”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.”
accuracyas written: “Mean accuracy (Agatston categories classification)”stated without valueCI 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%.”
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). 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).