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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, charged-particle, medical
510(k) Number K172848
Device Name MEVION S250i Proton Beam Radiation Therapy Device
Applicant
Mevion Medical Systems
300 Foster St.
Littleton,  MA  01460
Applicant Contact Thomas H. Faris
Correspondent
Mevion Medical Systems
300 Foster St.
Littleton,  MA  01460
Correspondent Contact Thomas H. Faris
Regulation Number892.5050
Classification Product Code
LHN  
Date Received09/19/2017
Decision Date 12/27/2017
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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