AccuContour
K221706Manteia Technologies Co., Ltd. · cleared 2023-03-09 · product code QKB · Radiology
Premarket evidence — what FDA accepted
source quote (p.4)
“The proposed device, AccuContour, is a standalone software which is used by radiation oncology department to register multi-modality images and segment (non-contrast) CT images, to generate needed information for treatment planning, treatment evaluation and treatment adaptation.”
source quote (p.4)
“Deep learning contouring: it can automatically contour organs-at-risk, in head and neck, thorax, abdomen and pelvis (for both male and female) areas,”
Validation studies (2)
Bench
sample size not stated
endpoints: Normalized Mutual Information (NMI)
Bench
sample size not stated
standards: FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices."
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
- re_clearance
The FDA AI/ML device list shows a newer 510(k) K251351 (decision 2026-01-23) from Manteia Technologies Co., Ltd. for a matching device line ("AccuContour 4.0") — a new clearance for the same line is a change event.
first seen 2026-07-08 · k_number:K251351
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).