Radiology · 510(k) · 2026
Median LCS (internal name) / eyonis LCS (trade name) (1.0)
Median Technologies. Cleared by FDA on 6 February 2026 under submission K251474, product code QDQ (radiological computer assisted detection/diagnosis software for lesions suspicious for cancer). What FDA's record says, in FDA's words.
Device record · K251474
- Device. Median LCS (internal name) / eyonis LCS (trade name) (1.0)DEVICE
- Company. Median Technologies (FR)COMPANY
- Decision. 6 February 2026, 510(k), substantially equivalent (traditional review); received 13 May 2025DECISION
- Panel. RadiologyPANEL
- Product code. QDQ, Radiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicious For CancerCODE
- Regulation. 21 CFR 892.2090, Class IIREG
- Source. FDA database entry · decision document (12 pages)SOURCE
Retrieved · the fields above are FDA's; the statement below was copied from the decision document on that day.
What FDA cleared it for
The Indications for Use statement, verbatim, from the decision document.
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. Median Technologies Document Title: eyonisLCS1.1_K251474_510(k) Summary Doc # eyonisLCS1.1_K251474_510(k) Summary Version 01 8 Comparison of Technological Characteristics with the Predicate Device eyonis LCS has […]
The product code's definition, from FDA's classification record. A radiological computer assisted detection and diagnostic software for suspected lesions is an image processing device intended to aid in the detection, localization, and characterization of lesions suspicious for cancer on acquired medical images (e.g., mammography , MR, CT, ultrasound, radiography). The device detects, identifies and characterizes lesions suspicious for cancer based on features or information extracted from the images, and may provide information about the presence, location, and characteristics of the lesion to the user. Primary diagnostic and patient management decisions are made by the clinical user.
What the statement says
Pattern matches on the Indications for Use text. Each line is a fact that the text contains the words, not a finding about the device.
- Modalities namedCT
- Mentionsan adjunct to the clinician, not a replacement
- Mentionsdetection or identification of findings
- Mentionsmeasurement or quantification
- Mentionsa diagnostic claim
Adverse-event reports in MAUDE, by product code
As of , MAUDE held 0 reports filed against devices carrying product code QDQ. That code is shared by every device of this type, not this device alone, and MAUDE reports are submitted by manufacturers, facilities and the public without FDA verification.
Where this fits
This page is a record, not medical advice and not a safety rating. It copies FDA's fields and FDA's statement, and lists what the statement's text mentions. Read the labeling before relying on any of it.
More devices under product code QDQ, in Radiology, or cleared in 2026. The whole record is at FDA AI-enabled medical devices.
A device's authorized use is a sentence the record can be read against. What Apodicta does on a medical record is that reading: every line of a note, a claim or a report proved to its source or held, before it renders.