FDA-cleared profile
Therapanacea Sas
ART-Plan+ assists trained radiation-therapy professionals with multimodal image review, registration, contouring, and the release-specific planning functions described in K253091. This release combined Annotate, prostate SmartPlan, and AdaptBox for supported head-and-neck, breast or thorax, and male-pelvis offline adaptive workflows, and added structures without changing the core indication.
Clinical fit
Start with the authorized purpose, then verify how it fits your service line and reading workflow.
Added in P2 round17 from the exact FDA decision material; later product-family claims remain separate.
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 architecture, data flow, identity, audit, encryption, retention, support-access, vulnerability-management, and incident-response evidence.
This release combined Annotate, prostate SmartPlan, and AdaptBox for supported head-and-neck, breast or thorax, and male-pelvis offline adaptive workflows, and added structures without changing the core indication. Procurement should map the installed build, modules, models, anatomies, inputs, and outputs to K253091 before acceptance.
exact submission · checked 2026-09-03Later product-family features are not evidence that an earlier cleared release includes them.
DICOM 3.0 import, export, and network exchange with imaging systems and treatment-planning systems; exact supported objects and automation depend on the cleared release and local configuration.
exact submission · checked 2026-09-03Test representative imports, exports, identifiers, orientation, geometry, structure names, units, failure handling, and round trips in the local environment.
Use a signed local test set spanning supported anatomies, scanners, protocols, unusual or postsurgical anatomy, and small or complex structures. Measure edit burden, rejection, downstream plan effects, and reviewer agreement rather than relying only on average overlap metrics.
product family · checked 2026-09-03Define stop-use, escalation, rollback, and revalidation triggers before production use.
Model total annual and per-plan cost against hands-on and elapsed time after review, correction, failed transfers, rework, support, upgrades, downtime, and any effect on plan quality or throughput.
product family · checked 2026-09-03Vendor time-saving results are scenario inputs, not guaranteed local savings.
Monitor by exact software and model version, anatomy, structure, scanner and protocol, patient position, contrast, unusual or postsurgical anatomy, reviewer role, edit time, rejected outputs, DICOM-transfer failures, downstream plan effects, incidents, recalls, and updates. Revalidate after material workflow or model changes.
product family · checked 2026-09-03Trend failures and edits by exact software version, model, anatomy, scanner, protocol, and site.
Evidence
Metrics are shown only when they are tied to a source, endpoint, population, and tested product version.
Sensitivity is not an applicable primary endpoint for this radiation-planning software. Review structure-, model-, workflow-, and release-specific geometric, clinical-review, dosimetric, and edit-burden evidence instead.
Specificity is not an applicable primary endpoint for this radiation-planning software. Review structure-, model-, workflow-, and release-specific geometric, clinical-review, dosimetric, and edit-burden evidence instead.
Reviewers in the multi-vendor contouring study in Multi-region radiotherapy contour review.
Tested version: ART-Plan product family; exact build not reportedManufacturer software verification and validation with release-specific contouring, registration, synthetic-CT, planning, dose, or adaptation tests as applicable · Release-specific multi-region radiotherapy images, structures, registrations, and planning workflows described in the FDA summary
exact submission · Tested version: ART-Plan+ v3.1.0 · Sponsor or vendor studyK253091
Manufacturer evidence submitted for substantial equivalence. This release combined Annotate, prostate SmartPlan, and AdaptBox for supported head-and-neck, breast or thorax, and male-pelvis offline adaptive workflows, and added structures without changing the core indication.
Blinded comparative review of eight commercial contouring programs by 20 radiation oncologists · Adult and pediatric radiation-therapy contours across head and neck, thorax or breast, abdomen, and pelvis
product family · Tested version: ART-Plan product family; exact tested build was not tied to every FDA submission in this batch · n=20 · Independent studyPMCID PMC11580215
The study reported that all evaluated systems required physician correction and should not be treated as exact-version validation.
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 release was found. Obtain a written quote separating license basis, sites or users, enabled modules or models, implementation, interfaces, compute, storage, training, support, upgrades, renewal, and exit costs.
No separate named-product payment identified in reviewed CMS 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. Maintain ongoing FDA and vendor surveillance.
Buyer worksheet
Research record
This audit distinguishes completed source review from fields that have not yet been researched.
Twenty PubMed records and one trial record were screened. They address adaptive radiotherapy generally or other systems and do not identify ART-Plan+ v3.1.0/K253091 as the tested release. No evidence was promoted, and all 21 candidates remain quarantined. The current discovery snapshot contains 20 PubMed and 1 ClinicalTrials.gov candidate records; its dated, count-matched human screening remains current. Unlinked candidates remain quarantined. Native FDA recall identifiers produced 0 postmarket candidate records; 0 have been reviewed (0 published, 0 rejected) and 0 remain unreviewed.
Candidate leads were screened against the exact product and tested version. Unlinked records remain quarantined.
Source classes: fda ai list, fda decision summary, vendor product page, peer reviewed publication, health technology guidance, reimbursement policy, fda device recall, fda decision material, literature index, trial registry, pubmed, clinical trials, openfda device recall
Sources
Sources accessed through 2026-09-04.
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