Radiology AI Directory

FDA-cleared profile

ART-Plan+ (v.3.0.0)

Therapanacea SAS

ART-Plan assists trained radiation-therapy professionals with multimodal image review, registration, contouring, and the release-specific planning functions described in K242822. This release included Annotate and TumorBox contouring plus SmartPlan automatic prostate-plan generation for import into the treatment-planning system for dose calculation, review, and approval.

Radiotherapy planningProstate imagingOncology quantification
Evidence status: each field states its source quality, applicability, and review date. Research pending, information not established, and vendor documentation pending remain distinct outcomes.

Clinical details

What this tool is for

Start with the authorized purpose, then verify how it fits your service line and reading workflow.

Exact purpose
ART-Plan assists trained radiation-therapy professionals with multimodal image review, registration, contouring, and the release-specific planning functions described in K242822. This release included Annotate and TumorBox contouring plus SmartPlan automatic prostate-plan generation for import into the treatment-planning system for dose calculation, review, and approval.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-04
Intended users
Trained medical professionals involved in radiation therapy, including radiation oncologists, radiotherapists, medical physicists, dosimetrists, radiologists, and other qualified planning staff as specified by the release labeling.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-04
Care setting and population
Radiation-therapy departments in hospitals, clinics, and other qualified treatment-planning facilities.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-04
Workflow role
Radiotherapy image processing, contouring, planning, and release-dependent offline adaptation support
  • Public source
  • Exact FDA submission
  • Checked 2026-09-04
Required input
DICOM radiation-planning images and objects. Release-dependent inputs include CT, MR, PET-CT, CBCT, 4D-CT, RT Structure Sets, prescriptions, and user-defined planning or adaptation parameters.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-04
Output and human action
Release-dependent outputs include reviewed contours and registrations, synthetic or pseudo-CT images, calculated dose information, replanning-assessment metrics, or an automatic plan for import into a treatment-planning system. Qualified users remain responsible for review and approval.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-04
Limitations
The software is an assistive radiation-planning system, not an autonomous treatment decision maker. Outputs require qualified review, correction, and approval before treatment use. FDA labeling excludes patients younger than 18 years for the later ART-Plan lineage reviewed in this batch; confirm the exact installed release labeling.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-04

Regulatory identity

FDA record and catalog context

The FDA listing establishes the regulatory identity. It does not by itself establish local workflow fit, pricing, security, or performance in your environment.

FDA submission
K242822
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-31
Modality
Radiotherapy Planning Imaging
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-04
Anatomy
Multi-region
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-04
Clearance type
510(k)
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-31
Decision date
2025-02-25
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-31
FDA status
FDA-cleared
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-31

Implementation

Questions for IT, informatics, and operations

Use these fields to structure a vendor demo, security review, and implementation estimate.

Integration
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.
  • Public source
  • Exact FDA submission
  • Checked 2026-09-04
Deployment and data flow
Software platform used in radiation-therapy hospitals and clinics. FDA summaries describe account-based projects, browser-accessible functions in later releases, DICOM network exchange, and batch-mode operations; hosting, tenancy, interfaces, and compute sizing require site-specific confirmation.
  • Public source
  • Exact FDA submission
  • Checked 2026-09-04
Security and privacy
Not established in reviewed sources
  • Reviewed sources checked
  • Exact FDA submission
  • Checked 2026-09-04

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.

Training and support
Only trained and qualified radiation-therapy professionals should operate the software and review, correct, and approve its outputs. Local onboarding must include release-specific limitations, failure examples, escalation, and competency documentation.
  • Public source
  • Exact FDA submission
  • Checked 2026-09-04
Monitoring and change control
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.
  • Public source
  • Exact FDA submission
  • Checked 2026-09-04

Release and scope verification

This release included Annotate and TumorBox contouring plus SmartPlan automatic prostate-plan generation for import into the treatment-planning system for dose calculation, review, and approval. Procurement should map the installed build, modules, models, anatomies, inputs, and outputs to K242822 before acceptance.

exact submission · checked 2026-09-04

Later product-family features are not evidence that an earlier cleared release includes them.

Source

Interoperability acceptance

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 2026-09-04

Test representative imports, exports, identifiers, orientation, geometry, structure names, units, failure handling, and round trips in the local environment.

Source

Clinical acceptance

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 2026-09-04

Define stop-use, escalation, rollback, and revalidation triggers before production use.

SourceSource

Economic evaluation

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 2026-09-04

Vendor time-saving results are scenario inputs, not guaranteed local savings.

Source

Lifecycle monitoring

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 2026-09-04

Trend failures and edits by exact software version, model, anatomy, scanner, protocol, and site.

SourceSourceSource

Deployment boundary

The exact installed deployment, hosting, service, security, and operational boundary remains unverified and requires site-specific confirmation.

exact submission · checked 2026-09-04

FDA-described deployment details do not establish current hosting contracts, security controls, uptime, or local qualification.

Source

Evidence

Performance 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.

Evidence summary
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.
  • Public source
  • Exact FDA submission
  • Checked 2026-09-04
Reported sensitivity
Not applicable
  • Not applicable
  • Exact FDA submission
  • Checked 2026-09-04

Sensitivity is not an applicable primary endpoint for this radiation-planning software. Review structure-, model-, workflow-, release-specific geometric, clinical-review, dosimetric, and edit-burden evidence instead.

Reported specificity
Not applicable
  • Not applicable
  • Exact FDA submission
  • Checked 2026-09-04

Specificity is not an applicable primary endpoint for this radiation-planning software. Review structure-, model-, workflow-, release-specific geometric, clinical-review, dosimetric, and edit-burden evidence instead.

Blinded review panel

20 radiation oncologists

  • EndpointReviewers in the multi-vendor contouring study
  • PopulationMulti-region radiotherapy contour review
  • Tested versionART-Plan product family; exact build not reported
Source

K242822 FDA performance package for ART-Plan+ (v.3.0.0)

  • DesignManufacturer software verification and validation with release-specific contouring, registration, synthetic-CT, planning, dose, or adaptation tests as applicable
  • PopulationRelease-specific multi-region radiotherapy images, structures, registrations, and planning workflows described in the FDA summary
  • Scopeexact submission
  • Tested versionART-Plan+ v3.0.0
  • IndependenceSponsor or vendor study

K242822

Manufacturer evidence submitted for substantial equivalence. This release included Annotate and TumorBox contouring plus SmartPlan automatic prostate-plan generation for import into the treatment-planning system for dose calculation, review, and approval.

Source

Blinded multi-vendor clinical review of automatic OAR and lymph-node contouring

  • DesignBlinded comparative review of eight commercial contouring programs by 20 radiation oncologists
  • PopulationAdult and pediatric radiation-therapy contours across head and neck, thorax or breast, abdomen, and pelvis
  • Scopeproduct family
  • Tested versionART-Plan product family; exact tested build was not tied to every FDA submission in this batch
  • Samplen=20
  • IndependenceIndependent study

PMCID PMC11580215

The study reported that all evaluated systems required physician correction and should not be treated as exact-version validation.

Source

K242822 FDA evidence package for ART-Plan+ (v.3.0.0)

  • DesignFDA 510(k) verification and validation evidence described in the exact submission
  • PopulationMulti-region
  • Scopeexact submission
  • Tested versionART-Plan+ v3.0.0
  • IndependenceSponsor or vendor study

K242822

Manufacturer evidence submitted for the exact FDA decision. It is not independent clinical validation, and local technical, clinical, privacy, security, and workflow acceptance remains necessary.

Source

Costs and setup

Budget and ongoing governance

These are common procurement questions; unknown values remain visible until a source supports them.

Pricing and total cost
Not established in reviewed sources
  • Reviewed sources checked
  • Exact FDA submission
  • Checked 2026-09-04

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.

Reimbursement and coding
No separate named-product Medicare payment was identified in the reviewed CMS Radiation Oncology Model material. Evaluate the product within the radiation-therapy planning service line using net staff time after review, plan quality, rework, throughput, implementation cost, and recurring cost.
  • Public source
  • Not applicable
  • Checked 2026-09-04

No product-specific code

No separate named-product payment identified in reviewed CMS material

Centers for Medicare & Medicaid Services · United States

Build a local total-cost and value model; do not infer reimbursement from FDA clearance.

Source

No product-specific code

No separate named-product payment identified in reviewed CMS material

Centers for Medicare & Medicaid Services · United States

This is not a product-specific reimbursement determination. Verify payer, site-of-service, coding, and coverage assumptions independently.

Source

Safety and lifecycle

Postmarket record

Recall and adverse-event records are shown only after product matching. Adverse-event reports do not establish incidence or causality.

Postmarket safety review
The 2026-09-02 openFDA device-recall snapshot contained no record matched to K242822 by exact submission identifier.
  • Public source
  • Exact FDA submission
  • Checked 2026-09-04

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

Open questions to take to the vendor

Open evaluation checklist

Research record

What has been checked

This audit distinguishes completed source review from fields that have not yet been researched.

Human reviewedStatus
2026-09-04Last searched
25Fields reviewed
13Source classes checked
20Screened PubMed leads
1Screened trial leads
0Unreviewed FDA recall leads

Screened 20 PubMed titles and one trial record. None identifies ART-Plan+ v3.0.0 or K242822 and establishes the tested release; all 21 candidates are quarantined as adaptive-radiotherapy topic matches. 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, peer reviewed literature, clinical trial registry, pubmed, clinical trials, openfda device recall

Sources & history

How this profile was documented

Open the ledger for source dates, scope, and research-record updates.

View source ledger and history

Source ledger

  1. FDA 510(k) decision material K242822: ART-Plan+ (v.3.0.0)

    U.S. Food and Drug Administration - Published 2025-02-25 - Accessed 2026-09-04

    Scope: identity, purpose, clinicalUse, modality, anatomy, intendedUsers, careSetting, workflowRole, input, output, limitations, evidenceSummary

  2. Artificial Intelligence-Enabled Medical Devices

    U.S. Food and Drug Administration - Accessed 2026-08-31

    Scope: regulatoryIdentity, modalityContext

  3. PubMed biomedical literature index

    U.S. National Library of Medicine - Accessed 2026-09-01

    Scope: evidenceDiscovery

  4. ClinicalTrials.gov study registry

    U.S. National Library of Medicine - Accessed 2026-09-01

    Scope: evidenceDiscovery, studyStatus

  5. Medicare Coverage Database

    Centers for Medicare & Medicaid Services - Accessed 2026-09-01

    Scope: coverage, codingContext

  6. openFDA Device Recall API

    U.S. Food and Drug Administration - Accessed 2026-09-02

    Scope: recallDiscovery, nativeSubmissionMatching

  7. Radiation Oncology Model

    Centers for Medicare & Medicaid Services - Accessed 2026-09-02

    Scope: reimbursement, radiationTherapyPaymentContext

  8. Artificial intelligence technologies to aid contouring for radiotherapy treatment planning

    National Institute for Health and Care Excellence - Published 2023-09-27 - Accessed 2026-09-02

    Scope: limitations, training, pricing, evidenceSummary, economics, monitoring, implementationCapabilities

  9. ART-Plan AI application suite for radiotherapy

    TheraPanacea SAS - Accessed 2026-09-03

    Scope: productFamily, workflowRole, integration, deployment, currentCommercialContext, implementationCapabilities

  10. AdaptBox offline adaptive radiotherapy workflow

    TheraPanacea SAS - Accessed 2026-09-03

    Scope: workflowRole, integration, deployment, currentCommercialContext, implementationCapabilities

  11. Artificial intelligence contouring in radiotherapy for organs-at-risk and lymph node areas

    BMC Cancer - Accessed 2026-09-03

    Scope: limitations, evidenceSummary, evidenceStudy, evidenceMetrics, monitoring, implementationCapabilities

  12. Guidance on selecting and evaluating AI auto-segmentation systems in clinical radiotherapy

    Journal of Applied Clinical Medical Physics - Accessed 2026-09-03

    Scope: limitations, evidenceSummary, economics, monitoring, implementationCapabilities

Research history

  1. K242822 FDA decision

    Regulatory record

    510(k)

  2. Source-review record updated

    Research record

    human reviewed

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