# K234068: ART-Plan (v.2.2.0)

- Pathway: 510(k) (Traditional)
- Applicant: Therapanacea Sas
- Decided: Apr 22, 2024 after 122 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: 19 generations back to K954874 (1996). 225 ancestors in all.
No later device cites it as a predicate yet.
1 of 226 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K232479: ART-Plan, Therapanacea (2023) Summary page 4.

## 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 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.

Source page: https://510kreport.com/device/K234068
Methodology: https://510kreport.com/methodology