LumiNE US; Lumi
K240094Augmedit B.V. · cleared 2024-09-10 · product code QIH · Radiology
Premarket evidence — what FDA accepted
Device typesamd
source quote (p.6)
“LumiNE US is a software device for the visualization of medical images to provide insights in anatomy and pathology in preparation of surgical treatment.”
Algorithmmachine learning (nnUnet)
source quote (p.12)
“The algorithms were originally trained using machine learning (nnUnet).”
Adaptive (vs locked)No
source quote (p.7)
“Substantially equivalent, the subject device has a more specific common name because of the presence of nonadaptive machine learning algorithms.”
PCCPFDA source did not state this
Cybersecurity addressedYes
source quote (p.13)
“Details and reports are included in Section Software/Firmware and Cybersecurity and Interoperability and Section Performance Testing.”
Validation studies (2)
Retrospective clinical
sample size not stated
endpoints: Dice Similarity Coefficient (DSC); 95% Hausdorff Distance (95% HD)
Bench
sample size not stated
standards: IEC63145-20-20, IEC63145-20-10
Reported performance (4 observations)
diceas written: “DSC (Brain)”0.96CI 0.95-0.97
source quote (p.12)
“For brain, the 95% CI of the median Dice (0.96, 95% CI 0.95-0.97) was totally above the established criterium (Dice 0.9).”
diceas written: “DSC (Skin)”0.99CI 0.99-0.1
source quote (p.12)
“For skin, the 95% CI of the median Dice (0.99, 95% CI 0.99-0.1) was totally above the established criterium (Dice 0.9).”
diceas written: “DSC (Tumor)”0.93CI 0.92-0.94
source quote (p.12)
“For tumor, the 95% CI of the median Dice (0.93, 95% CI 0.92-0.94) was totally above the established criterium (Dice 0.8).”
diceas written: “DSC (Ventricles)”0.89CI 0.85-0.91
source quote (p.12)
“For ventricles, the 95% CI of the median Dice (0.89, 95% CI 0.85-0.91) was totally above the established criterium (Dice 0.85).”
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
3
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).