# K230685: AutoContour Model RADAC V3

- Pathway: 510(k) (Special)
- Applicant: Radformation, Inc.
- Decided: Apr 14, 2023 after 32 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 K913770 (1991). 115 ancestors in all.
5 later devices descend from it; 2 cite 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)
- K220598: AutoContour Model RADAC V2, Radformation, Inc. (2022) Summary page 7.

## Most influential descendants
- 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
- K262452: AutoContour (RADAC V6) (2026), 0 descendants of its own
- K260528: OncoStudio (2026), 0 descendants 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/K230685
Methodology: https://510kreport.com/methodology