# K260528: OncoStudio

- Pathway: 510(k) (Traditional)
- Applicant: Oncosoft. Inc.,
- Decided: Jul 2, 2026 after 135 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: 17 generations back to K913770 (1991). 117 ancestors in all.
No later device cites it as a predicate yet.
0 of 118 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K242994: OncoStudio (OS-01), Oncosoft. Co., Ltd. (2025) Summary page 6.

## Indications for use
OncoStudio is intended to assist radiation treatment planners in contouring and reviewing structures within medical images in preparation for radiation therapy treatment planning. It also supports the review, processing, and analysis of medical imaging and radiotherapy information within the radiation therapy planning workflow.

Source page: https://510kreport.com/device/K260528
Methodology: https://510kreport.com/methodology