# K200323: AutoContour

- Pathway: 510(k) (Traditional)
- Applicant: Radformation, Inc.
- Decided: Oct 30, 2020 after 263 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: 13 generations back to K913770 (1991). 113 ancestors in all.
7 later devices descend from it; 1 cites it directly.
0 of 121 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K130393: Mirada RTX, Mirada Medical, Ltd. (2013) Summary page 5.
- K181572: Workflow Box, Mirada Medical, Ltd. (2018) Summary page 5.

## Most influential descendants
- K220598: AutoContour Model RADAC V2 (2022), 6 descendants of its own
- K230685: AutoContour Model RADAC V3 (2023), 5 descendants of its own
- K242729: AutoContour (Model RADAC V4) (2024), 2 descendants of its own
- K260509: AutoContour (RADAC V5) (2026), 1 descendant of its own
- K242994: OncoStudio (OS-01) (2025), 1 descendant of its own

## Indications for use
AutoContour is intended to assist radiation treatment planners in contouring and reviewing structures within medical images in preparation for radiation therapy treatment planning.

Source page: https://510kreport.com/device/K200323
Methodology: https://510kreport.com/methodology