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 K230023. This special 510(k) added 48 structures to existing Annotate localizations, extended support to workflows including lung SBRT, and included eight bug fixes without changing the indication.
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 architecture, data flow, identity, audit, encryption, retention, support-access, vulnerability-management, and incident-response evidence.
This special 510(k) added 48 structures to existing Annotate localizations, extended support to workflows including lung SBRT, and included eight bug fixes without changing the indication. Procurement should map the installed build, modules, models, anatomies, inputs, and outputs to K230023 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.
Structures added to existing Annotate localizations in ART-Plan testing described in K230023.
Tested version: ART-Plan v1.10.1Bug fixes included in the special 510(k) in ART-Plan testing described in K230023.
Tested version: ART-Plan v1.10.1Reviewers 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 v1.10.1 · Sponsor or vendor studyK230023
Manufacturer evidence submitted for substantial equivalence. This special 510(k) added 48 structures to existing Annotate localizations, extended support to workflows including lung SBRT, and included eight bug fixes without changing the 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.
Recovered from the prior exact-submission extraction and normalized under the current provenance rules. Exact FDA decision materials, current product-family materials, directly relevant clinical literature, reimbursement context, and exact-identifier recall candidates were reviewed. Pricing, final security architecture, contracted services, enabled modules or models, interoperability, and local acceptance remain organization-specific evidence. Automated exact-name discovery found 20 PubMed and 1 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, peer reviewed publication, health technology guidance, reimbursement policy, fda device recall, pubmed, clinical trials, openfda device recall
Sources
Sources accessed through 2026-09-03.
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