Cleared Traditional

Median LCS (internal name) / eyonis LCS (trade name) (1.0)

K251474 · Median Technologies · Radiology
Feb 2026
Decision
269d
Days
Class 2
Risk

About This 510(k) Submission

K251474 is an FDA 510(k) clearance for the Median LCS (internal name) / eyonis LCS (trade name) (1.0), a Radiological Computer Assisted Detection/diagnosis Software For Lesions Suspicious For Cancer (Class II — Special Controls, product code QDQ), submitted by Median Technologies (Valbonne, FR). The FDA issued a Cleared decision on February 6, 2026, 269 days after receiving the submission on May 13, 2025. This device falls under the Radiology review panel. Regulated under 21 CFR 892.2090.

Submission Details

510(k) Number K251474 FDA.gov
FDA Decision Cleared SESE
Date Received May 13, 2025
Decision Date February 06, 2026
Days to Decision 269 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF

Device Classification

Product Code QDQ — Radiological Computer Assisted Detection/diagnosis Software For Lesions Suspicious For Cancer
Device Class Class II — Special Controls
CFR Regulation 21 CFR 892.2090
Definition 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.