TeraRecon Cardiac.Chambers.MR (1.0.0)

K241312

TeraRecon,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 algorithms
source quote (p.7)
“The technology utilized by both the subject and predicate device to provide segmentation of cardiac anatomical structures is the same as both devices utilize supervised deep learning 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 (2)

Retrospective clinical

n=50 patients

endpoints: LV Myocardium DICE score; LV chamber DICE score; RV Chamber DICE score

Retrospective clinical

n=50 patients

endpoints: LV segmentation DICE score; MYO segmentation DICE score

Reported performance (5 observations)

diceas written: “LV Myocardium mean DICE score (Cine-ax)”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: “LV Chambers mean DICE Score (Cine-ax)”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: “RV Chamber mean DICE Score (Cine-ax)”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: “LV myocardium mean DICE score (De-ax)”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: “LV Chamber mean DICE score (De-ax)”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); 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/K241312