# K230082: Auto Segmentation

- Pathway: 510(k) (Traditional)
- Applicant: Ge Medical Systems, LLC
- Decided: May 4, 2023 after 113 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.
1 later device descends from it; 1 cites it directly.
1 of 103 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) Summary page 4.

## Most influential descendants
- K242925: MR Contour DL (2025), 0 descendants of its own

## Indications for use
Auto Segmentation generates a Radiotherapy Structure Set (RTSS) DICOM with segmented organs at risk which can be used by dosimetrists, medical physicists, and radiation oncologists as initial contours to accelerate workflow for radiation therapy planning. It is the responsibility of the user to verify the processed output contours and user-defined labels for each organ at risk and correct the contours/labels as needed. Auto Segmentation may be used with images acquired on CT scanners, in adult patients.

Source page: https://510kreport.com/device/K230082
Methodology: https://510kreport.com/methodology