# K230023: ART-Plan

- Pathway: 510(k) (Special)
- Applicant: Therapanacea Sas
- Decided: Apr 19, 2023 after 105 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: 17 generations back to K954874 (1996). 164 ancestors in all.
3 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)
- K220813: Art-Plan, Therapanacea (2022) Summary page 5.

## Most influential descendants
- 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 indicated for cancer patients for whom radiation treatment has been planned. It is intended to be used by trained medical professionals including, but not limited to, radiologists, radiation oncologists, dosimetrists, and medical physicists. ART-Plan is a software application intended to display and visualize 3D multi-modal medical image data. The user may mport, define, display, transform and store DICOM3.0 compliant datasets (including regions of interest structures). These images, contours and objects can subsequently be exported/distributed within the system, across computer networks and/or to radiation treatment planning systems. Supported modalities include CT, PET-CT, CBCT, 4D-CT and MR images. ART-Plan supports AI-based contouring on CT and MR images and offers semi-automatic and manual tools for segmentation. To help the user assess changes in image data and to obtain combined multi-modal image information, ART-Plan allows the registration of anatomical and functional images and display of fused and non-fused images to facilitate the comparison of patient image data by the user. With ART-Plan, users are also able to generate, visualize, evaluate and modify pseudo-CT from MRI images.

Source page: https://510kreport.com/device/K230023
Methodology: https://510kreport.com/methodology