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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 K233622
Device Name AlignRT Plus
Applicant
Vision Rt, Ltd.
Dove House, Arcadia Ave.
London,  GB N3 2JU
Applicant Contact Ludlow Chelsey
Correspondent
Vision Rt, Ltd.
Dove House, Arcadia Ave.
London,  GB N3 2JU
Correspondent Contact Ludlow Chelsey
Regulation Number892.5050
Classification Product Code
IYE  
Date Received11/13/2023
Decision Date 03/29/2024
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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