# K261306: AI Contouring (VA10A)

- Pathway: 510(k) (Traditional)
- Applicant: Varian Medical Systems
- Decided: Jul 10, 2026 after 81 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 5.

## Indications for use
AI Contouring is a post-processing software intended to automatically contour CT and MR structures, including known (diagnosed) brain metastases, using deep-learning-based algorithms. Contours that are generated by AI Contouring may be used as input for clinical workflows for radiation therapy treatment planning. AI Contouring 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 Contouring. The outputs of AI Contouring are intended to be used by qualified and trained medical professionals.

Source page: https://510kreport.com/device/K261306
Methodology: https://510kreport.com/methodology