Radiation Planning Assistant

FDA 510(k)

Class II (US FDA 510(k))

510(k) K222728

by University of Texas, MD Anderson Cancer Center

Identifiers

510(k) Number: K222728 FDA 510(k)
FDA Product Code: MUJ FDA 510(k)

Classification

Device Class: Class II FDA 510(k)
Legislation / Framework: 21 CFR Part 892.5050 FDA 510(k)
Regulation Number: 892.5050 FDA 510(k)
Advisory Committee: Radiology FDA 510(k)
FDA Decision: SESE Substantially Equivalent FDA 510(k)

The Radiation Planning Assistant is a system for radiation therapy treatment planning. It utilizes a suite of automated contouring and radiotherapy planning tools to assist in the creation of treatment plans.

This web-based tool is accessed by uploading a CT scan and submitting a service request to initiate the automated planning workflow. The device is classified as a Class 2 medical device and has received FDA 510(k) clearance.

Frequently asked questions

What is the primary function of the Radiation Planning Assistant?

The Radiation Planning Assistant is designed to assist in the creation of radiation therapy treatment plans. It achieves this by utilizing a suite of automated contouring and radiotherapy planning tools.

How is the Radiation Planning Assistant accessed by clinicians?

This is a web-based tool. Clinicians access the system by uploading a CT scan and submitting a service request to initiate the automated planning workflow.

What is the regulatory status of this device?

The Radiation Planning Assistant is classified as a Class 2 medical device and has received FDA 510(k) clearance under K222728.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Radiation Planning Assistant | MD Anderson Cancer Center, About | Radiation Planning Assistant, Radiation Planning Assistant: Delivering on the promise of AI

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

Source	Region	Type	Cert / Approval No.	Class	Status
FDA 510(k)	United States	FDA_510K	K222728	Class II	Active

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Manufacturer

Manufacturer: University of Texas, MD Anderson Cancer Center

Sources (1)

FDA 510(k) K222728 24 fields · synced Oct 6, 2026