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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 K253012
Device Name AlignRT Plus (8.0)
Applicant
Vision Rt, Ltd.
Dove House, Arcadia Ave.
London,  GB N3 2JU
Applicant Contact Chelsey Moore
Correspondent
Vision Rt, Ltd.
Dove House, Arcadia Ave.
London,  GB N3 2JU
Correspondent Contact Chelsey Moore
Regulation Number892.5050
Classification Product Code
IYE  
Date Received09/19/2025
Decision Date 03/18/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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