AccessGUDID - DEVICE: Radiation Planning Assistant (RPA) (00040695000008)

GUDID

Device Identifier (DI) Information

Brand Name: Radiation Planning Assistant (RPA)
Version or Model: 1.0.0.5
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: The University of Texas M. D. Anderson Cancer Center

Primary DI Number: 00040695000008
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 800772139 *Terms of Use

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.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
40887	Radiation therapy software	An application software program intended to facilitate/support the delivery of therapeutic radiation by enabling computer-assisted functionality in one or more of the following areas: treatment planning, simulation, record/verify, beam block CAD/CAM, quality assurance, and patient positioning. Some types may be combined with specific hardware or firmware accessories or configurations in order to function as intended.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MUJ	System, Planning, Radiation Therapy Treatment

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K222728	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 6ec5aded-cfdb-4680-a2d1-74710bbcc4d6
Public Version Date: February 05, 2025
Public Version Number: 1
DI Record Publish Date: January 28, 2025