TeraRecon Aorta.CT (1.1.0)

K243158

TeraRecon, Inc. · cleared 2025-01-23 · product code QIH · Radiology

Premarket evidence — what FDA accepted

Device typesamd

source quote (p.4)

“TeraRecon Aorta.CT is a software as a medical device (SaMD) deployed as a containerized application.”

AlgorithmSupervised deep learning-based algorithms

source quote (p.7)

“Supervised deep learning-based algorithms”

Adaptive (vs locked)No

PCCPFDA source did not state this

Cybersecurity addressedFDA source did not state this

Validation studies (1)

Retrospective clinical

n=170 patients · 3 site(s)

endpoints: Lumen Segmentation (DICE score); Aorta wall segmentation (DICE score); Landmarking results (Euclidean distance, class-specific criteria, 95% exact binomial confidence interval)

Reported performance (2 observations)

diceas written: “Mean DICE score for lumen segmentation”88

source quote (p.9)

“The lumen segmentation results passed with a mean DICE score of 88%.”

diceas written: “Mean DICE score for aorta segmentation”90

source quote (p.9)

“The aorta segmentation results passed with a mean DICE score of 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

recalls in product code, 24mo

MAUDE reports in code, 12mo

—

vs code's own 3-yr baseline

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).