# K232899: AI-Rad Companion Organs RT

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Medical Solutions U.S.A.
- Decided: Apr 3, 2024 after 198 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). 103 ancestors in all.
3 later devices descend from it; 1 cites it directly.
1 of 107 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K221305: AI-Rad Companion Organs RT, Siemens Medical Solutions USA, Inc. (2022) Summary page 5.

## Most influential descendants
- K242745: AI-Rad Companion Organs RT (2025), 2 descendants of its own
- K261306: AI Contouring (VA10A) (2026), 0 descendants of its own
- K252548: AI-Rad Companion Organs RT (2026), 0 descendants of its own

## Indications for use
AI-Rad Companion Organs RT is a post-processing software intended to automatically contour DICOM CT and MR predefined structures using deep-leaming-based algorithms. Contours that are generated by AI-Rad Companion Organs RT may be used as input for clinical workflows including external beam radiation therapy treatment planning. AI-Rad Companion Organs RT must be used in conjunction with appropriate software such as Treatment Planning Systems and Interactive Contouring applications, to review, edit, and accept contours generated by AI-Rad Companion Organs RT. The output of AI-Rad Companion Organs RT are intended to be used by trained medical professionals. The software is not intended to automatically detect or contour lesions.

Source page: https://510kreport.com/device/K232899
Methodology: https://510kreport.com/methodology