Median LCS (internal name) / eyonis LCS (trade name) (1.0)
K251474Median Technologies · cleared 2026-02-06 · product code QDQ · Radiology
Premarket evidence — what FDA accepted
source quote (p.5)
“eyonis® LCS is an AI/ML technology-based end-to-end CADe/CADx Software as Medical Device (SaMD) intended to allow early detection, localization and characterization of pulmonary parenchymal nodules from LDCT DICOM images produced during Chest CT examinations.”
source quote (p.8)
“The device includes ‘deep learning’ modules for recognition of suspicious lesions.”
source quote (p.9)
“Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions”
Validation studies (2)
Standalone
n=1,147 patients · 7 site(s)
endpoints: patient-level AUROC; sensitivity at COT; specificity at COT; AULROC; FROC analysis
standards: IEC 62366-1, ISO 20417, ISO 14971, IEC 62304, IEC 82304-1, ISO 15223-1, NEMA PS 3.1
Reader study (MRMC)
n=480 images
endpoints: image-level Area Under the Curve (AUC) of the Receiver Operating Characteristic (ROC) curve; Sensitivity; Specificity; inter-reader agreement per patient score; inter-reader agreement per patient management
Reported performance (8 observations)
source quote (p.10)
“a sensitivity at COT of 84.50% [80.22-88.17] p<0.0001”
source quote (p.10)
“a specificity at COT of 80.25% [77.33-82.95] p<0.0001”
source quote (p.10)
“a patient-level AUROC of 0.904 [0.881-0.926] p<0.0001”
source quote (p.10)
“an AULROC of 0.869 [0.843-0.894] p<0.0001”
source quote (p.10)
“FROC analysis yielded a sensitivity at COT of 80.59% [76.20-84.49]”
source quote (p.10)
“a false-positive rate of 0.271 [0.235-0.313] per scan.”
source quote (p.11)
“aided AUC = 0.8434”
source quote (p.11)
“∆AUC (aided – unaided) = 0.0158 [0.0032-0.0288]”
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
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).