# K193562: AI-Rad Companion Organs RT

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Medical Solutions USA, Inc.
- Decided: Nov 6, 2020 after 319 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). 101 ancestors in all.
6 later devices descend from it; 1 cites 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)
- K191928: AccuContour, Xiamen Manteia Technology, Ltd. (2020). Cleared while this submission was under review Summary page 5.

## Most influential descendants
- K221305: AI-Rad Companion Organs RT (2022), 5 descendants of its own
- 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

## Indications for use
Al-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 Al-Rad Companion Organs RT may be used as input for clinical workflows including external beam radiation therapy treatment planning. Al-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 Al-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/K193562
Methodology: https://510kreport.com/methodology