Radiation Planning Assistant (RPA)

Primary DI
00040695000008
Brand
Radiation Planning Assistant (RPA)
Company
The University of Texas M. D. Anderson Cancer Center
Model
1.0.0.5
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.
Published
2025-01-28
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
MUJSystem, Planning, Radiation Therapy Treatment

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MUJSystem, Planning, Radiation Therapy TreatmentRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K222728000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K222728000Radiation Planning Assistant (RPA)University of Texas, MD Anderson Cancer Center2023-05-17MUJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00040695000008PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00040695000008000406950000080406950000080040695000008

GMDN Terms#

Term, Definition table
TermDefinition
Radiation therapy softwareAn 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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
800772139
Device count
1

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00860015780805INTContourCarina Medical LLCMUJ2026-04-27
08436567540024RadianceGMV SOLUCIONES GLOBALES INTERNET SAMUJ2026-04-08
07340201500118MonacoElekta Solutions ABMUJ2026-03-20
00850072631004ClearCalcRadformation, IncMUJ2026-03-13
00860001672787ClearCalcRadformation, IncMUJ2026-03-13
00860001672794EZFluenceRadformation, IncMUJ2026-03-13
07340201503898Leksell GammaPlanElekta Solutions ABMUJ2026-02-04
05060494200091XBeam XSTRAHL LIMITEDMUJ2026-01-19
03770019940013ART-PlanTHERAPANACEAMUJ2025-12-10
03770019940020ART-PlanTHERAPANACEAMUJ2025-12-10
04056869959009syngo.via RT Image SuiteSiemens Healthcare GmbHMUJ2025-11-18
04068151011388syngo.via RT Image SuiteSiemens Healthcare GmbHMUJ2025-11-18
00860014658303PinZ Patient ImmobilizerZAP SURGICAL SYSTEMS, INC.MUJ2025-11-17
00860183001542Kit, Container, Head ImmobilizerZAP SURGICAL SYSTEMS, INC.MUJ2025-11-17
00860183001573ZAP-Axon Treatment Planning SystemZAP SURGICAL SYSTEMS, INC.MUJ2025-11-17
00860183001580DoseGuardZAP SURGICAL SYSTEMS, INC.MUJ2025-11-17
00860183001597Kit, Container, Fixation Pins, ImmobilizerZAP SURGICAL SYSTEMS, INC.MUJ2025-11-17
08717213058118NANucletron B.V.MUJ2025-11-13
05060608881574Plan AISUN NUCLEAR CORP.MUJ2025-11-07
06429830064237Dose+Mvision AI OyMUJ2025-10-03
07350002010891RayCareRaysearch Laboratories AB (Publ)MUJ2025-09-30
04056481146030RT Elements Brainlab SEMUJ2025-06-25
07350002010839RayCareRaysearch Laboratories AB (Publ)MUJ2025-04-30
07350002010884RayStationRaysearch Laboratories AB (Publ)MUJ2025-04-10
00855141006349Eclipse Treatment Planning SystemVARIAN MEDICAL SYSTEMS, INC.MUJ2024-12-20
00856100006370ARIA Radiation Therapy ManagementVARIAN MEDICAL SYSTEMS, INC.MUJ2024-12-20
00859032007170Panther TPSProwess, Inc.MUJ2024-12-19
00859032007194Panther TPSProwess, Inc.MUJ2024-12-19
00859032007200Panther TPSProwess, Inc.MUJ2024-12-19
00859032007231Panther TPSProwess, Inc.MUJ2024-12-19