# K242822: ART-Plan+ (v.3.0.0)

- Pathway: 510(k) (Traditional)
- Applicant: Therapanacea Sas
- Decided: Feb 25, 2025 after 160 days
- Product code: MUJ (System, Planning, Radiation Therapy Treatment)
- Device class: 2
- Regulation: 21 CFR 892.5050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 16 generations back to K010975 (2001). 20 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 22 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K222728: Radiation Planning Assistant (RPA), University of Texas, MD Anderson Cancer Center (2023) Summary page 5.

## Most influential descendants
- K253091: ART-Plan+ (v3.1.0) (2025), 0 descendants of its own

## Indications for 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.

Source page: https://510kreport.com/device/K242822
Methodology: https://510kreport.com/methodology