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FDA-cleared K253091

ART-Plan+ (v3.1.0)

Therapanacea Sas

Authorized purpose: 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.

Modality
Radiotherapy Planning Imaging
Anatomy
Multi-region
Decision
2025-12-23
FDA-cleared K242822

ART-Plan+ (v.3.0.0)

Therapanacea SAS

Authorized 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.

Modality
Radiotherapy Planning Imaging
Anatomy
Multi-region
Decision
2025-02-25
FDA-cleared K234068

ART-Plan (v.2.2.0)

Therapanacea SAS

Authorized purpose: ART-Plan v2.2.0 assists trained radiation therapy professionals with multimodality contouring and registration, automatic treatment planning, synthetic CT, dose computation, and offline replanning assessment.

Modality
Radiotherapy Planning Imaging
Anatomy
Multi-region
Decision
2024-04-22
FDA-cleared K230023

ART-Plan

Therapanacea SAS

Authorized purpose: ART-Plan v1.10.1 assists trained radiation therapy professionals with multimodality registration and reviewed CT or MR contouring; this release added 48 structures to existing localizations, including support relevant to lung SBRT workflows.

Modality
Radiotherapy Planning Imaging
Anatomy
Multi-region
Decision
2023-04-19