# K232479: ART-Plan

- Pathway: 510(k) (Traditional)
- Applicant: Therapanacea
- Decided: Dec 22, 2023 after 128 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: 18 generations back to K954874 (1996). 224 ancestors in all.
2 later devices descend from it; 2 cite it directly.
1 of 227 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K212294: Ethos Treatment Management, Ethos Treatment Planning, Varian Medical Systems, Inc. (2021) Summary page 6.
- K230023: ART-Plan, Therapanacea Sas (2023) Summary page 6.

## Most influential descendants
- K253078: ART.1-US (2026), 0 descendants of its own
- K234068: ART-Plan (v.2.2.0) (2024), 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 is not intended 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.

Source page: https://510kreport.com/device/K232479
Methodology: https://510kreport.com/methodology