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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Image Processing, Radiological
510(k) Number K243069
Device Name LUMYS (V1)
Applicant
INTRADYS
37 rue Jean Marie Le Bris
BREST,  FR 29200
Applicant Contact Tiffany VAZ
Correspondent
INTRADYS
37 rue Jean Marie Le Bris
BREST,  FR 29200
Correspondent Contact Tiffany VAZ
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received09/27/2024
Decision Date 05/02/2025
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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