FDA-cleared profile
University of Texas, MD Anderson Cancer Center
RPA creates initial CT-based contours and photon external-beam treatment plans for head-and-neck, cervical, breast, and whole-brain radiotherapy for export to a treatment-planning system.
Clinical fit
Start with the authorized purpose, then verify how it fits your service line and reading workflow.
Regulatory identity
The FDA listing establishes the regulatory identity. It does not by itself establish local workflow fit, pricing, security, or performance in your environment.
Implementation
Use these fields to structure a vendor demo, security review, and implementation estimate.
Public materials reviewed for this batch do not establish the complete security posture for the exact release. Request data-flow, identity, audit, encryption, retention, support-access, vulnerability-management, backup, and incident-response evidence.
Map the installed model, build, options, population, anatomy, inputs, and outputs to K222728 before acceptance.
exact submission · checked 2026-09-03Later product-family features are not evidence that this cleared release includes them.
Uses some Eclipse 15.6 functions and exports contours and plans to the user's TPS; validate DICOM transfer, structure naming, beam model, machine configuration, dose recalculation, plan integrity, and failure recovery.
exact submission · checked 2026-09-03Test representative identifiers, orientation, geometry, measurements, units, routing, failure handling, and round trips locally.
Use a signed local test set for the supported population and workflow. Include common and difficult cases, exclusions, acquisition variation, failed or low-quality inputs, reviewer overrides, and downstream effects. RPA is not a primary treatment-planning system. Every contour and plan must be imported into the user's TPS for review, editing, and final dose calculation; unsupported disease sites, techniques, machines, or local protocols must not be inferred.
exact submission · checked 2026-09-03Define stop-use, escalation, rollback, and revalidation triggers before production use.
Model capital and recurring cost against net staff time after review, throughput, repeat imaging or rework, room time, consumables, infrastructure, training, service, downtime, upgrade, and replacement costs.
product family · checked 2026-09-03Vendor productivity claims are scenario inputs, not guaranteed local savings.
Monitor by exact hardware, software and model version, patient population, anatomy, protocol, operator, input quality, output edits or overrides, failed studies, repeat acquisition or rework, downstream impact, downtime, incidents, recalls, and updates. Track the limits that matter for this product: RPA is not a primary treatment-planning system. Every contour and plan must be imported into the user's TPS for review, editing, and final dose calculation; unsupported disease sites, techniques, machines, or local protocols must not be inferred.
exact submission · checked 2026-09-03Revalidate after material software, hardware, model, protocol, interface, or clinical-policy changes.
Evidence
Metrics are shown only when they are tied to a source, endpoint, population, and tested product version.
Sensitivity is not the primary applicable endpoint for this acquisition, reconstruction, segmentation, planning, guidance, or quantitative-biomarker function. Use the task-specific endpoints and tested population reported below.
Specificity is not the primary applicable endpoint for this acquisition, reconstruction, segmentation, planning, guidance, or quantitative-biomarker function. Use the task-specific endpoints and tested population reported below.
Multicenter planning evaluation in Radiation Planning Assistant (RPA).
Tested version: Radiation Planning Assistant release cleared in K222728RPA head-and-neck plan evaluation in Radiation Planning Assistant (RPA).
Tested version: Radiation Planning Assistant release cleared in K222728RPA cervical VMAT plan evaluation in Radiation Planning Assistant (RPA).
Tested version: Radiation Planning Assistant release cleared in K222728Body contours within 2 mm for 95% of CT scans in Radiation Planning Assistant (RPA).
Tested version: Radiation Planning Assistant release cleared in K222728Agreement in all orthogonal directions for 95% of cases in Radiation Planning Assistant (RPA).
Tested version: Radiation Planning Assistant release cleared in K222728Manufacturer multicenter external evaluation of automated contours and treatment plans against clinical contours, plans, and dosimetric criteria · Cervical, post-mastectomy chest-wall, head-and-neck, and whole-brain radiotherapy cases from five clinical sites
exact submission · Tested version: Radiation Planning Assistant release cleared in K222728 · 5 sites · Sponsor or vendor studyK222728
Manufacturer evidence submitted for substantial equivalence; local clinical, technical, and workflow acceptance remains necessary.
Economics and lifecycle
These are common procurement questions; unknown values remain visible until a source supports them.
No public list price for the exact cleared configuration was found. Obtain a written quote separating hardware or license basis, enabled features, implementation, interfaces, infrastructure, training, service, upgrades, renewal, consumables, and exit costs.
No separate named-product payment identified in reviewed public material
Centers for Medicare & Medicaid Services · United StatesBuild a local total-cost and value model; do not infer reimbursement from FDA clearance.
Safety and lifecycle
Recall and adverse-event records are shown only after product matching. Adverse-event reports do not establish incidence or causality.
A zero-result exact-identifier search does not prove that no recall, correction, adverse-event report, or product-family safety signal exists.
Buyer worksheet
Research record
This audit distinguishes completed source review from fields that have not yet been researched.
Recovered from the prior exact-submission extraction and normalized under the current provenance rules. Exact FDA materials, current product-family sources, selected clinical literature, reimbursement context, and exact-identifier recall candidates were reviewed. Pricing, contracted services, enabled options, final security architecture, and local interoperability remain organization-specific evidence. Automated exact-name discovery found 20 PubMed and 0 ClinicalTrials.gov candidate records. Candidates require human product and version matching; zero candidates is not evidence that no studies exist. Native FDA recall identifiers produced 0 postmarket candidate records; 0 have been reviewed (0 published, 0 rejected) and 0 remain unreviewed.
Candidate leads remain unpublished until a human confirms the exact product and tested version.
Source classes: fda ai list, fda decision summary, vendor product page, reimbursement policy, fda device recall, pubmed, clinical trials, openfda device recall
Sources
Sources accessed through 2026-09-03.
Alternatives
Therapanacea Sas
ART-Plan+ assists trained radiation-therapy professionals with multimodal image review, registration, contouring, and the release-specific planning functions described in K253091....
MVision AI Oy
Contour+ generates initial CT and MR anatomical contours across head and neck, brain, breast, thoracoabdominal, and pelvic radiation-treatment planning workflows for qualified...
Radformation, Inc.
AutoContour Model RADAC V5 assists radiation treatment planners with contouring and reviewing structures in medical images for radiation therapy treatment planning. It produces...
Elekta Solutions AB
The EMLA family delivers external-beam radiation therapy for adult and pediatric patients with benign, malignant, or metastatic disease. Authorized techniques vary by model:...