AccuContour
K191928Xiamen Manteia Technology LTD. · cleared 2020-02-28 · product code QKB · Radiology
Premarket evidence — what FDA accepted
Device typesamd
source quote (p.5)
“The proposed device, AccuContourTM, is a standalone software which is used by radiation oncology department to register multimodality images and segment (non-contrast) CT images, to generate needed information for treatment planning, treatment evaluation and treatment adaptation.”
AlgorithmDeep Learning
source quote (p.5)
“Deep learning contouring: it can automatically contour the organ-at-risk, including head and neck, thorax, abdomen and pelvis (for both male and female)”
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
sample size not stated
endpoints: DICE similarity coefficients (DSC)
Retrospective clinical
sample size not stated
endpoints: Normalized Mutual Information (NMI)
Reported performance (1 observation)
diceas written: “DICE similarity coefficients (DSC)”stated without value
source quote (p.6)
“DICE similarity coefficients (DSC) was used for evaluation. DSC values were calculated on two sets of images for test group and control group, respectively. According to the results, it could be concluded that the DSC of proposed device was non-inferiority compared with that of the predicate device.”
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). 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).