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 with GPU/CPU support
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)

Retrospective clinical

n=247 images

endpoints: Dice Similarity Coefficient (DSC); 95% Hausdorff Distance (HD95); clinical applicability (1-5 scale scoring system)

Retrospective clinical

n=30 images · 2 site(s)

endpoints: Dice Similarity Coefficient (DSC); clinical appropriateness (1-5 scale scoring system)

Reported performance (4 observations)

diceas written: “DSC Mean (TemporalLobe_L, MR images)”0.879CI 0.854 (95% CI Lower Bound)
source quote (p.11)
“Table 1: Test Results for synthetic CT generated from MR images”
diceas written: “DSC Mean (BrachialPlexus L, CBCT images)”0.823CI 0.805 (95% CI Lower Bound)
source quote (p.12)
“Table 2: Test Results for sCT generated from CBCT”
diceas written: “DSC Mean (Trachea, Rigid Registration)”0.907CI 0.888 (95% CI Lower Bound)
source quote (p.13)
“Table 3: Test Results after Rigid Registration for Each ROI”
diceas written: “DSC Mean (Trachea, Deformable Registration)”0.946CI 0.940 (95% CI Lower Bound)
source quote (p.13)
“Table 4: Test Results after Deformable Registration for Each ROI”

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
0
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/K251351