# K251474: Median LCS (internal name) / eyonis LCS (trade name) (1.0)

- Pathway: 510(k) (Traditional)
- Applicant: Median Technologies
- Decided: Feb 6, 2026 after 269 days
- Product code: QDQ (Radiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicious For Cancer)
- Device class: 2
- Regulation: 21 CFR 892.2090
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to DEN180005 (2018). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K241831: Transpara (2.1.0), Screenpoint Medical B.V. (2024) Summary page 5.

## Indications for use
eyonis® LCS is indicated for use by radiologists. eyonis® LCS assists radiologists in the detection, localization and characterization of solid and part-solid probably benign, suspicious and very suspicious pulmonary parenchymal nodules with a diameter of 4-30 mm (pure ground glass, mediastinal lesions and masses - including but not limited to hilar masses - are excluded). The eyonis® LCS - lung nodules result report provides, for each reported nodule, the following information: slice number, malignancy score, full snapshot, close-up snapshot, diameters (long/short/average) and volume. The eyonis® LCS - lung nodules result report is indicated to aid in diagnosis as well as to aid in follow-up exam evaluations and as an adjunct to support clinical/patient management. It cannot, however, substitute for medical experts’ clinical judgment. The target population is high-risk patients eligible for participation in lung cancer screening programs (as per USPSTF criteria) with the exception of patients with pure ground glass cancer only and hilar/mediastinal cancer who are excluded from the intended population. It is indicated for use with low-dose Chest CT DICOM images. The exact specifications are described in a DICOM Conformance Statement (DCS) document.

Source page: https://510kreport.com/device/K251474
Methodology: https://510kreport.com/methodology