therapanacea.euART-Plan+ (v.3.0.0)
Therapanacea Sas
THERAPANACEA
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3019834893 | 3019834893 | THERAPANACEA | 1 | N | 2026-01-01 | 7 bis boulevard Bourdon Paris Paris FR 75004 |
GUDID Contact Samples#
| Source GUDID | Product | Phone | |
|---|---|---|---|
| 03770019940006 | ART-Plan - The current version of the medical device includes the Annotate and the SmartFuse module that intends to help the practitioner to delineate organs at risks manually, semi-automatically and automatically. The Smartfuse module is also providing the possibility to do a fusion of images from different modalities. This version also contains an administration module, that allows the user to manage data and rights. | +330620604982 | b.ajachandra@therapanacea.eu |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 293725 | 1915148629 | K242822 | ART-Plan+ (v.3.0.0) | MUJ | 2025-02-25 |
| 293725 | 1291425371 | K234068 | ART-Plan (v.2.2.0) | MUJ | 2024-04-22 |
| 293725 | 1338414169 | K232479 | ART-Plan | MUJ | 2023-12-22 |
| 293725 | 1862784023 | K230023 | ART-Plan | QKB | 2023-04-19 |
| 293725 | 1884926627 | K220813 | ART-PLAN | QKB | 2022-06-17 |
| 293725 | 1630091052 | K202700 | ART-Plan | QKB | 2021-01-14 |
Product Codes Associated With Registrations#
PMN#
ART-Plan (v.2.2.0)
Therapanacea Sas
ART-Plan
Therapanacea
ART-Plan
Therapanacea Sas
ART-PLAN
TheraPanacea
ART-Plan
TheraPanacea
GUDID#
ART-Plan - The current version of the medical device includes the Annotate, SmartFuse and AdaptBox modules. The Annotate module intends to help the practitioner to delineate organs at risks manually, semi-automatically and automatically. The Smartfuse module is also providing the possibility to do a fusion of images from different modalities. The Adaptbox module is a helping tool to decide if a replanning is necessary. For this purpose, the module allows the user to generate a synthetic-CT from a CBCT image, to auto-delineate regions of interest on the synthetic-CT, to compute the dose on both planning CT and synthetic-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. This version also contains an administration module, that allows the user to manage data and rights.
2025-12-10
ART-Plan - The current version of the medical device includes the Annotate, SmartFuse, SmartPlan and AdaptBox modules. The Annotate module allow the contouring of regions of interest. The module Smartplan allows the creation of an automatic treatment plan based on a planning CT and a RTSS The Smartfuse module is also providing the possibility to do a fusion of images from different modalities. The Adaptbox module is a helping tool to decide if a replanning is necessary. For this purpose, the module allows the user to generate a synthetic-CT from a CBCT image, to auto-delineate regions of interest on the synthetic-CT, to compute the dose on both planning CT and synthetic-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. This version also contains an administration module, that allows the user to manage data and rights.
2025-12-10
ART-Plan - The current version of the medical device includes the Annotate and the SmartFuse module that intends to help the practitioner to delineate organs at risks manually, semi-automatically and automatically. The Smartfuse module is also providing the possibility to do a fusion of images from different modalities. This version also contains an administration module, that allows the user to manage data and rights.
2022-10-26