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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Planning, Radiation Therapy Treatment
510(k) Number K213787
Device Name Monaco RTP System
Applicant
Elekta Solutions AB
Kungstensgatan 18 Box 7593
Stockholm,  SE SE10393
Applicant Contact Anju Kurian
Correspondent
Elekta Solutions AB
Kungstensgatan 18 Box 7593
Stockholm,  SE SE10393
Correspondent Contact Anju Kurian
Regulation Number892.5050
Classification Product Code
MUJ  
Date Received12/06/2021
Decision Date 05/17/2022
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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