# K202700: ART-Plan

- Pathway: 510(k) (Traditional)
- Applicant: Therapanacea
- Decided: Jan 14, 2021 after 120 days
- Product code: QKB (Radiological Image Processing Software For Radiation Therapy)
- Device class: 2
- Regulation: 21 CFR 892.2050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 15 generations back to K954874 (1996). 162 ancestors in all.
5 later devices descend from it; 1 cites it directly.
1 of 168 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K191928: AccuContour, Xiamen Manteia Technology, Ltd. (2020) Summary page 6.
- K130393: Mirada RTX, Mirada Medical, Ltd. (2013) Summary page 6.
- K181572: Workflow Box, Mirada Medical, Ltd. (2018) Summary page 6.
- K071964: Mim 4.1 (Seastar), Mimvista Corp. (2007) Summary page 6.

## Most influential descendants
- K220813: Art-Plan (2022), 4 descendants of its own
- K230023: ART-Plan (2023), 3 descendants of its own
- K232479: ART-Plan (2023), 2 descendants of its own
- 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 is a software designed to assist the contouring process of the target anatomical regions on 3D-images of cancer patients for whom radiotherapy treatment has been planned. The SmartFuse module allows the user to register combinations of anatomical and functional images and display them with fused and non-fused displays to facilitate the comparison and delineation of image data by the user. The images created with rigid or elastic registration require verifications, potential modifications, and then the validation of a trained user with professional qualifications in anatomy and radiotherapy. With the Annotate module, users can edit manually and semi-automatically the contours for the regions of interest. It also allows to generate automatically, and based on medical practices, the contours for the organs at risk and healthy lymph nodes on CT images. The contours created automatically, semi-automatically or manually require verifications, potential modifications, and then the validation of a trained user with professional qualifications in anatomy and radiotherapy. The device is intended to be used in a clinical setting, by trained professionals only.

Source page: https://510kreport.com/device/K202700
Methodology: https://510kreport.com/methodology