510(k) K222728

Radiation Planning Assistant (RPA) by University Of Texas, MD Anderson Cancer Center — Product Code MUJ

K222728 is an FDA 510(k) premarket notification submitted by University Of Texas, MD Anderson Cancer Center for the device "Radiation Planning Assistant (RPA)". The FDA issued a decision of Substantially Equivalent on May 17, 2023. The device falls under product code MUJ (System, Planning, Radiation Therapy Treatment), a Class II device regulated under 21 CFR 892.5050.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 17, 2023
Date Received
Sep 8, 2022
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Planning, Radiation Therapy Treatment
Device Class
Class II
Regulation Number
892.5050
Review Panel
RA
Submission Type
510(k)