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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 K183037
Device Name Monaco RTP System
Applicant
Elekta, Inc
13723 Riverport Drive, Suite 100
Maryland Heights,  MO  63043
Applicant Contact Kathryn Stinson
Correspondent
Elekta, Inc
13723 Riverport Drive, Suite 100
Maryland Heights,  MO  63043
Correspondent Contact Kathryn Stinson
Regulation Number892.5050
Classification Product Code
MUJ  
Date Received11/01/2018
Decision Date 12/04/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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