# K221305: AI-Rad Companion Organs RT

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Medical Solutions USA, Inc.
- Decided: Oct 14, 2022 after 162 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: 16 generations back to K954874 (1996). 102 ancestors in all.
5 later devices descend from it; 2 cite it directly.
1 of 108 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K193562: AI-Rad Companion Organs RT, Siemens Medical Solutions USA, Inc. (2020) Summary page 5.

## Most influential descendants
- K232899: AI-Rad Companion Organs RT (2024), 3 descendants of its own
- 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
- K232928: DeepContour (V1.0) (2024), 0 descendants of its own

## Indications for use
AI-Rad Companion Organs RT is a post-processing software intended to automatically contour DICOM CT imaging data using deep-learning-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 in the format of RTSTRUCT objects are intended to be used by trained medical professionals. The software is not intended to automatically detect or contour lesions. Only DICOM images of adult patients are considered to be valid input.

Source page: https://510kreport.com/device/K221305
Methodology: https://510kreport.com/methodology