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510(k) Data Aggregation
K Number
K222728Device Name
Radiation Planning Assistant (RPA)
Manufacturer
University of Texas, MD Anderson Cancer Center
Date Cleared
2023-05-17
(251 days)
Product Code
MUJ
Regulation Number
892.5050Why did this record match?
Applicant Name (Manufacturer) :
University of Texas, MD Anderson Cancer Center
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Radiation Planning Assistant (RPA) is used to plan radiotherapy treatments with cancers of the head and neck, cervix, breast, and metastases to the brain. The RPA is used to plan external beam irradiation with photon beams using CT images. The RPA is used to create contours and treatment plans that the user imports into their own Treatment Planning System (TPS) for review, editing, and re-calculation of the dose.
Some functions of the RPA use Eclipse 15.6. The RPA is not intended to be used as a primary treatment planning system. All automatically generated contours and plans must be imported into the user's own treatment planning system for review, edit, and final dose calculation.
Device Description
The Radiation Planning Assistant (RPA) is a web-based contouring and radiotherapy treatment planning software tool that incorporates the basic radiation planning functions from automated contouring, automated planning with dose optimization, and quality control checks. The system is intended for use for patients with cancer of the head and neck, cervix, breast, and metastases to the brain. The RPA system is integrated with the Eclipse Treatment Planning System v15.6 software cleared under K181145. The RPA radiation treatment planning software tool was trained against hundreds / thousands of CT Scans of normal and diseased tissues from patients receiving radiation for head and neck, cervical, breast, and whole brain at MD Anderson Cancer Center.
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