# K252548: AI-Rad Companion Organs RT

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Healthcare GmbH
- Decided: Apr 10, 2026 after 240 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: 19 generations back to K954874 (1996). 105 ancestors in all.
No later device cites it as a predicate yet.
1 of 106 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K242745: AI-Rad Companion Organs RT, Siemens Healthcare GmbH (2025) Summary page 6.

## Indications for use
AI-Rad Companion Organs RT is a post-processing software intended to automatically contour DICOM CT and MR pre-defined structures, including known (diagnosed) brain metastases, using deep-learning-based algorithms. Contours that are generated by AI-Rad Companion Organs RT may be used as input for clinical workflows including 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 outputs of AI-Rad Companion Organs RT are intended to be used by qualified and trained medical professionals. The software is not intended to be used for diagnostic purposes.

Source page: https://510kreport.com/device/K252548
Methodology: https://510kreport.com/methodology