# K211881: AI Segmentation

- Pathway: 510(k) (Traditional)
- Applicant: Varian Medical Systems, Inc.
- Decided: Sep 2, 2021 after 73 days
- Product code: MUJ (System, Planning, Radiation Therapy Treatment)
- Device class: 2
- Regulation: 21 CFR 892.5050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 11 generations back to K010975 (2001). 22 ancestors in all.
No later device cites it as a predicate yet.
0 of 23 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K203469: AI Segmentation, Varian Medical Systems, Inc. (2021) Summary page 4.

## Indications for use
AI Segmentation uses CT images to segment patient anatomy for use in radiation therapy treatment planning. AI Segmentation utilizes a pre-defined set of organ structures in the following regions: head and neck, thorax, pelvis, abdomen. Segmentation results are subject to review and editing by qualified, expert radiation therapy treatment planners. Results of AI Segmentation are utilized in the Eclipse Treatment Planning System where it is the responsibility of a qualified physician to further review, edit as needed, and approve each structure.

Source page: https://510kreport.com/device/K211881
Methodology: https://510kreport.com/methodology