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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 Route Des Crêtes
Valbonne,  FR 06560
Applicant Contact Laurence Boy-Machefer
Correspondent
Median Technologies
1800 Route 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
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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