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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name accelerator, linear, medical
510(k) Number K193431
Device Name AlignRT Plus
Applicant
Vision RT Ltd
Dove House, Arcadia Avenue
London,  GB N3 2JU
Applicant Contact Arun Mahendran
Correspondent
Vision RT Ltd
Dove House, Arcadia Avenue
London,  GB N3 2JU
Correspondent Contact Arun Mahendran
Regulation Number892.5050
Classification Product Code
IYE  
Date Received12/10/2019
Decision Date 01/03/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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