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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Radiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicious For Cancer
510(k) Number K251474
Device Name Median LCS (internal name) / eyonis LCS (trade name) (1.0)
Applicant
Median Technologies
1800 Rte. Des Crêtes
Valbonne,  FR 06560
Applicant Contact Laurence Boy-Machefer
Correspondent
Median Technologies
1800 Rte. Des Crêtes
Valbonne,  FR 06560
Correspondent Contact Laurence Boy-Machefer
Classification Product Code
QDQ  
Date Received05/13/2025
Decision Date 02/06/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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