TeraRecon Cardiac.Chambers.MR (1.0.0)
K241312TeraRecon,Inc. · cleared 2024-11-05 · product code QIH · Radiology
Premarket evidence — what FDA accepted
Device typesamd
source quote (p.5)
“The TeraReconCardiac.Chambers.MR algorithm for Cine-ax is an image processing software device that can be deployed as a containerized application (e.g.,Docker container).”
Algorithmsupervised deep learning based algorithms for segmentation
source quote (p.5)
“The TeraRecon Cardiac.Chambers.MR algorithm is comprised of two components: 1. The TeraRecon Cardiac.Chambers.MR for Cine-ax 2. The TeraRecon Cardiac.Chambers.MR De-ax”
Adaptive (vs locked)FDA source did not state this
PCCPNo
Cybersecurity addressedNo
Validation studies (1)
Retrospective clinical
n=100 patients · 3 site(s)
endpoints: LV Myocardium DICE score; LV chamber DICE score; RV Chamber DICE score
Reported performance (5 observations)
diceas written: “Cine-ax LV Myocardium mean DICE score”0.82CI 0.81,0.83
source quote (p.8)
“The results of the Cine-ax algorithm showed the LV Myocardium mean DICE scores for were within the acceptance criteria at 0.82 (0.81,0.83) and within the 95% confidence interval (CI).”
diceas written: “Cine-ax LV Chambers mean DICE Scores”0.9CI 0.89, 0.91
source quote (p.8)
“The results indicated the LV Chambers mean DICE Scores were within the acceptance criteria and were at or greater than 0.90 (0.89, 0.91) within the 95% confidence interval,,”
diceas written: “Cine-ax RV Chamber mean DICE Score”0.84CI 0.82, 0.85
source quote (p.8)
“and the mean DICE Score for RV Chamber was 0.84 (0.82, 0.85) and thus within the 95% confidence interval and passing the DICE limit score.”
diceas written: “De-ax LV myocardium mean DICE scores”0.79CI 0.75, 0.83
source quote (p.9)
“The results of the De-ax algorithm showed the LV myocardium mean DICE scores were within the acceptance criteria at 0.79 (0.75, 0.83),”
diceas written: “De-ax LV Chamber mean DICE scores”0.88CI 0.84, 0.92
source quote (p.9)
“and the LV Chamber mean DICE scores were within the acceptance criteria at 0.88 (0.84, 0.92).”
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).