AccuContour 4.0

K251351

Manteia Technologies Co., Ltd. · cleared 2026-01-23 · product code QKB · Radiology

Premarket evidence — what FDA accepted

Device typesamd

source quote (p.5)

“The proposed device, AccuContour 4.0 Family, is a standalone software with the following variants: AccuContour and AccuContour-Lite.”

AlgorithmDeep learning contouring and intensity-based registration

source quote (p.5)

“Deep learning contouring: it can automatically contour organs-at-risk, in head and neck, thorax, abdomen and pelvis (for both male and female) areas,”

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)

Standalone

n=247 images

endpoints: Dice Similarity Coefficient (DSC); 95% Hausdorff Distance (HD95); clinical applicability of the automatically delineated contours using a 1-5 scale scoring system

Standalone

n=30 other

endpoints: Dice Similarity Coefficient (DSC); qualitative clinical appropriateness of AccuContour structures generated on these scans was graded by clinical experts

Reported performance (0 observations)

FDA source did not state a quantitative performance metric — non-reporting is itself the signal.

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).