FDA-cleared profile
TheraPanacea
Authorized purpose: ART-Plan v1.10.0 assists trained radiation therapy professionals with multimodality DICOM review and registration, CT and MR contouring, and supported MR pseudo-CT generation, with qualified review before treatment-planning export.
Product overview
Authorized purpose: ART-Plan v1.10.0 assists trained radiation therapy professionals with multimodality DICOM review and registration, CT and MR contouring, and supported MR pseudo-CT generation, with qualified review before treatment-planning export.
Overview status: Source-reviewed overview
Clinical role: ART-Plan v1.10.0 assists trained radiation therapy professionals with multimodality DICOM review and registration, CT and MR contouring, and supported MR pseudo-CT generation, with qualified review before treatment-planning export.
Evidence from the reviewed source record: FDA submissions document release-specific software verification, contouring validation, registration checks, and, where applicable, synthetic-CT, dose, planning, or adaptation testing. Independent multi-vendor studies support clinical usefulness but also show structure- and site-dependent editing needs; they do not validate every ART-Plan release or establish patient-outcome benefit.
Clinical details
Start with the authorized purpose, then verify how it fits your service line and reading workflow.
Clinical-use display mirrors the exact FDA-supported purpose reconciled from the decision-summary packet.
The exact indications name the listed trained medical professionals; radiotherapists and the broader planning-staff wording are not stated in this packet.
The exact packet supports DICOM datasets, regions of interest structures, and the listed modalities; it does not establish prescriptions or user-defined planning/adaptation parameters as inputs.
The exact packet establishes export/distribution of images, contours, objects, and pseudo-CT functions; it does not state calculated dose, replanning metrics, or automatic-plan output.
This is the exact review and validation boundary. The active packet does not establish the dossier's under-18 exclusion statement.
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.
Exact FDA decision-summary packet reviewed on 2026-09-19; existing wording is supported without expansion.
Exact FDA decision-summary packet reviewed on 2026-09-19; existing wording is supported without expansion.
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 supported CT, MR, PET-CT, CBCT, and 4D-CT review and registration, AI contouring on CT and MR, and pseudo-CT generation from MR for supported anatomies. Procurement should map the installed build, modules, models, anatomies, inputs, and outputs to K220813 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. Candidate literature without exact product and version linkage is not shown as product evidence.
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.
20 radiation oncologists
K220813
Manufacturer evidence submitted for substantial equivalence. This release supported CT, MR, PET-CT, CBCT, and 4D-CT review and registration, AI contouring on CT and MR, and pseudo-CT generation from MR for supported anatomies.
PMCID PMC11580215
The study reported that all evaluated systems required physician correction and should not be treated as exact-version validation.
Costs and setup
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.
The refreshed discovery snapshot contains 20 PubMed and 1 ClinicalTrials.gov candidate records. Discovery metadata alone does not establish exact tested-product, version, population, and endpoint applicability, so all candidates remain quarantined and none was promoted. 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 summary packet, literature index, trial registry, pubmed, clinical trials, openfda device recall
Sources & history
Open the ledger for source dates, scope, and research-record updates.
Scope: purpose, modality, anatomy, intendedUsers, input, output, limitations, evidenceSummary, clinicalUse
Scope: regulatoryIdentity, modalityContext
Scope: evidenceDiscovery
Scope: evidenceDiscovery, studyStatus
Scope: recallDiscovery, nativeSubmissionMatching
Scope: reimbursement, radiationTherapyPaymentContext
Scope: limitations, training, pricing, evidenceSummary, economics, monitoring, implementationCapabilities
Scope: productFamily, workflowRole, integration, deployment, currentCommercialContext, implementationCapabilities
Scope: workflowRole, integration, deployment, currentCommercialContext, implementationCapabilities
Scope: limitations, evidenceSummary, evidenceStudy, evidenceMetrics, monitoring, implementationCapabilities
Scope: limitations, evidenceSummary, economics, monitoring, implementationCapabilities
Regulatory record
510(k)
Research record
fda record reviewed
Editorial review
Source-reviewed editorial overlay
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