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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Radiological Image Processing Software For Radiation Therapy
510(k) Number K212218
Device Name Advanced Algorithms for Treatment Management Applications (AATMA)
Applicant
Elekta Solutions AB
Kungstensgatan 18 Box 7593
Stockholm,  SE SE10393
Applicant Contact Melinda Smith
Correspondent
Elekta, Inc.
1450 Beale St., Suite 205
Saint Charles,  MO  63303
Correspondent Contact Anju Kurian
Regulation Number892.2050
Classification Product Code
QKB  
Subsequent Product Code
LLZ  
Date Received07/16/2021
Decision Date 10/25/2021
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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