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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 K222728
Device Name Radiation Planning Assistant (RPA)
Applicant
University of Texas, MD Anderson Cancer Center
1515 Holcombe Blvd.
Houston,  TX  77030
Applicant Contact Stella Tsai
Correspondent
University of Texas, MD Anderson Cancer Center
1515 Holcombe Blvd.
Houston,  TX  77030
Correspondent Contact Stella Tsai
Regulation Number892.5050
Classification Product Code
MUJ  
Date Received09/08/2022
Decision Date 05/17/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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