QOCA® image Smart RT Contouring System
K231855Quanta Computer Inc. · cleared 2024-02-13 · product code QKB · Radiology
Premarket evidence — what FDA accepted
Device typesamd
source quote (p.3)
“QOCA® image Smart RT Contouring System is a post-processing software intended to automatically contour DICOM CT imaging data using deep-learning-based algorithms.”
Algorithmdeep-learning-based algorithms
source quote (p.3)
“QOCA® image Smart RT Contouring System is a post-processing software intended to automatically contour DICOM CT imaging data using deep-learning-based algorithms.”
Adaptive (vs locked)FDA source did not state this
PCCPFDA source did not state this
Cybersecurity addressedYes
source quote (p.11)
“Content of Premarket Submission for Management of Cybersecurity in Medical Devices.”
Validation studies (1)
Retrospective clinical
n=220 cases
endpoints: DICE similarity coefficient (DSC); Hausdorff Distance 95th percentile (HD95)
standards: IEC 62304: 2006/A1:2016 - Medical device software - Software life cycle processes
Reported performance (2 observations)
diceas written: “Median DICE similarity coefficient (DSC)”0.8
source quote (p.14)
“The subject device achieved a median DSC > 0.80.”
diceas written: “DICE similarity coefficient (DSC) for Brain stem”0.942CI ±0.0215
source quote (p.13)
“Brain stem 0.942 (±0.0215)”
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).