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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Accelerator, Linear, Medical
510(k) Number K252188
Device Name EMLA (Elekta Evo); EMLA (VersaHD); EMLA (Elekta Harmony Pro); EMLA (Elekta Infintiy); EMLA (Elekta Harmony); EMLA (Elekta Synergy)
Applicant
Elekta Solutions AB
Hagaplan 4
Stockholm,  SE 113 68
Applicant Contact Lorenzo Muratori
Correspondent
Elekta Solutions AB
Hagaplan 4
Stockholm,  SE 113 68
Correspondent Contact Lorenzo Muratori
Regulation Number892.5050
Classification Product Code
IYE  
Date Received07/14/2025
Decision Date 01/15/2026
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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