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510(k) Data Aggregation
K Number
K242822Device Name
ART-Plan+ (v.3.0.0)
Manufacturer
Therapanacea SAS
Date Cleared
2025-02-25
(160 days)
Product Code
MUJ, LLZ, QKB
Regulation Number
892.5050Why did this record match?
Applicant Name (Manufacturer) :
Therapanacea SAS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
ART-Plan+'s indicated target population is cancer patients for whom radiotherapy treatment has been prescribed. In this population, any patient for whom relevant modality imaging data is available.
ART-Plan+'s includes several modules:
- SmartPlan which allows automatic generation of radiotherapy treatment plan that the users import into their own Treatment Planning System (TPS) for the dose calculation, review and approval. This module is available for supported prescriptions for prostate only.
- Annotate which allows automatic generation of contours for organs at risk, lymph nodes and tumors, based on medical practices, on medical images such as CT and MR images
ART-Plan+ is not intended to be used for patients less than 18 years of age.
The indicated users are trained medical professionals including, but not limited to, radiotherapists, radiation oncologists, medical physicists, dosimetrists and medical professionals involved in the radiation therapy process.
The indicated use environments include, but are not limited to, hospitals, clinics and any health facility offering radiation therapy.
Device Description
ART-Plan+ is a software platform allowing contour regions of interest on 3D images and to provide an automatic treatment plan. It includes several modules:
-Home: tasks
-Annotate and TumorBox: contouring of regions of interest
-SmartPlan: creation of an automatic treatment plan based on a planning CT and a RTSS
-Administration and settings : preferences management, user account management, etc.
-Institute Management: institute information, including licenses, list of users, etc.
-About: information about the software and its use, as well as contact details.
Annotate, TumorBox and SmartPlan are partially based on a batch mode, which allows the user to launch the operations of autocontouring and autoplanning without having to use the interface or the viewers. In that way, the software is completely integrated into the radiotherapy workflow and offer to the user a maximum of flexibility.
ART-Plan+ offers deep-learning based automatic segmentation of OARs and LNs for the following localizations:
-Head and neck (on CT images)
-Thorax/breast (on CT images)
-Abdomen (on CT and male on MR images)
-Pelvis male (on CT and MR images)
-Pelvis female (on CT images)
-Brain (on CT images and MR images)
ART-Plan+ offers deep-learning based automatic segmentation of targets for the following localizations:
-Brain (on MR images)
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K Number
K234068Device Name
ART-Plan (v.2.2.0)
Manufacturer
Therapanacea SAS
Date Cleared
2024-04-22
(122 days)
Product Code
MUJ, LLZ, QKB
Regulation Number
892.5050Why did this record match?
Applicant Name (Manufacturer) :
Therapanacea SAS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
ART-Plan's indicated target population is cancer patients for whom radiotherapy treatment has been prescribed. In this population, any patient for whom relevant modality imaging data is available.
ART-Plan is not intended to be used for patients less than 18 years of age.
The indicated users are trained medical professionals including, but not limited to, radiotherapists, radiation oncologists, medical physicists, dosimetrists and medical professionals involved in the radiation therapy process.
The indicated use environments are, but not limited to, hospitals, clinics and any health facility involved in radiation therapy.
Device Description
ART-Plan is a software platform allowing users with an account to contour regions of interest on 3D images, perform multi-model registration of images, and help in the decision for the need for replanning based on contours and doses on daily images. It includes several modules:
- Home,
- Annotate,
- SmartFuse,
- AdaptBox,
- Administration,
- About
ART-Plan asks the user to work by project. It is necessary to create a "project" entity in the Patient page by associating it to a reference volume (preferably the positioning CT or the positioning MR) in order to create the contours on this volume in the Annotate module or to use this image as reference to compare it with CBCT images in the AdaptBox module. It is possible to create several projects for a given patient.
The Home module allows the user to search for a patient already present in the software's database or to import it from the structure's imaging servers or from another external source and to manage the different projects of this patient.
The Annotate module allows the user to contour regions of interest on the reference volume. It also allows generation of pseudo-CTs from MRI images. Users are able to visualize, evaluate and modify the HU values of the associated structures on the pseudo-CT, if needed. After validation, manual and automatic contours can be generated on the pseudo-CT images. Registration can also be performed using the pseudo-CT either as a target or source image. All results can be exported upon approval.
The SmartFuse module allows the user to fuse the primary volume of a project with secondary volumes.
The AdapBox module helps the user to decide if a replanning is necessary. For this purpose, the module allows the user to generate a pseudo-CT from a CBCT image, to auto-delineate regions of interest on the pseudo-CT, to compute the dose on both planning CT and pseudo-CT and then define if there is a need for replanning by comparing volume and dose metrics computed on both images and over the course of the treatment. Those metrics are defined by the user.
The Administration module allows users with specific rights to manage the platform's usage parameters. Some more restricted rights are also accessible in the drop-down menu linked to the user account through the Settings menu.
The About module allows the user to obtain information about the software and its use, as well as to contact TheraPanacea.
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K Number
K230023Device Name
ART-Plan
Manufacturer
Therapanacea SAS
Date Cleared
2023-04-19
(105 days)
Product Code
QKB, LLZ, MUJ
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
Therapanacea SAS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
ART-Plan is indicated for cancer patients for whom radiation treatment has been planned. It is intended to be used by trained medical professionals including, but not limited to, radiologists, radiation oncologists, dosimetrists, and medical physicists.
ART-Plan is a software application intended to display and visualize 3D multi-modal medical image data. The user may import, define, display, transform and store DICOM3.0 compliant datasets (including regions of interest structures). These images, contours and objects can subsequently be exported/distributed within the system, across computer networks and/or to radiation treatment planning systems. Supported modalities include CT, PET-CT, CBCT, 4D-CT and MR images.
ART-Plan supports Al-based contouring on CT and MR images and offers semi-automatic and manual tools for segmentation.
To help the user assess changes in image data and to obtain combined multi-modal image information, ART-Plan allows the registration of anatomical and functional images and display of fused and non-fused images to facilitate the comparison of patient image data by the user.
With ART-Plan, users are also able to generate, visualize, evaluate and modify pseudo-CT from MRI images.
Device Description
The ART-Plan application consists of two kev modules: SmartFuse and Annotate, allowing the user to display and visualize 3D multi-modal medical image data. The user may process, render, review, store, display and distribute DICOM 3.0 compliant datasets within the system and/or across computer networks. Supported modalities cover static and gated CT (computerized tomography including CBCT and 4D-CT), PET (positron emission tomography) and MR (magnetic resonance).
The ART-Plan technical functionalities claimed by TheraPanacea are the following:
- Proposing automatic solutions to the user, such as an automatic delineation, automatic . multimodal image fusion, etc. towards improving standardization of processes/ performance / reducing user tedious / time consuming involvement.
- . Offering to the user a set of tools to assist semi-automatic delineation, semi-automatic reqistration towards modifying/editing manually automatically generated structures and adding/removing new/undesired structures or imposing user-provided correspondences constraints on the fusion of multimodal images.
- . Presenting to the user a set of visualization methods of the delineated structures, and registration fusion maps.
- . Saving the delineated structures / fusion results for use in the dosimetry process.
- Enabling rigid and deformable registration of patients images sets to combine information contained in different or same modalities.
- . Allowing the users to generate, visualize, evaluate and modify pseudo-CT from MRI images.
ART-Plan offers deep-learning based automatic segmentation for the following localizations:
- head and neck (on CT images) ●
- thorax/breast (for male/female and on CT images) ●
- abdomen (on CT images and MR images) ●
- pelvis male(on CT images and MR images) ●
- pelvis female (on CT images) ●
- brain (on CT images and MR images)
ART-Plan offers deep-learning based synthetic CT-generation from MR images for the following localizations:
- . pelvis male
- brain
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