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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Radiation Therapy, Radionuclide
510(k) Number K222047
Device Name Leksell Gamma Knife Perfexion, Leksell Gamma Knife Icon, Leksell Gamma Knife - Elekta Esprit (New model variant)
Applicant
Elekta Solutions AB
Kungstensgatan 18 Box 7593
Stockholm,  SE SE-10393
Applicant Contact Helena Skar
Correspondent
Elekta Solutions AB
Kungstensgatan 18 Box 7593
Stockholm,  SE SE-10393
Correspondent Contact Helena Skar
Regulation Number892.5750
Classification Product Code
IWB  
Date Received07/12/2022
Decision Date 10/26/2022
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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