Devices · University of Texas, MD Anderson Cancer Center

Radiation Planning Assistant (RPA)

510(k)K222728RadiologyMUJ

University of Texas, MD Anderson Cancer Center is listed for Radiation Planning Assistant (RPA) (K222728). The FDA list gives May 17, 2023 as the date of the final decision. The lead panel is Radiology, and the database link on the FDA list is the 510(k) pathway. The primary product code on the FDA list is MUJ. openFDA did not return a classification record for that code in this copy of the data. openFDA records this submission’s decision description as “Substantially Equivalent.” This paragraph is assembled only from those public fields. It is not an FDA review, not a determination of safety or effectiveness, and not medical advice. Official record: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K222728

Official FDA database record

Date of final decision: May 17, 2023
Company on the FDA list: University of Texas, MD Anderson Cancer Center
Lead panel: Radiology
Primary product code: MUJ
openFDA device name for the code: System, Planning, Radiation Therapy Treatment
Device class: 2
Regulation number: 892.5050
openFDA decision description: Substantially Equivalent
openFDA decision code: SESE
Statement or summary label: Summary