# K242994: OncoStudio (OS-01)

- Pathway: 510(k) (Traditional)
- Applicant: Oncosoft. Co., Ltd.
- Decided: Feb 24, 2025 after 151 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: 16 generations back to K913770 (1991). 116 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 118 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K230685: AutoContour Model RADAC V3, Radformation, Inc. (2023) Summary page 6.

## Most influential descendants
- K260528: OncoStudio (2026), 0 descendants of its own

## Indications for use
OncoStudio provides deep-learning-based automatic contouring to organs at risk in DICOM-RT format from CT images. This software could be used as an initial contouring for the clinicians to be confirmed by the radiation oncology department for treatment planning or other professions where a segmented mask of organs is needed. • Deep learning contouring from Head & Neck, Thorax, Abdomen, and Pelvis • Generates DICOM-RT structure of contoured objects • Manual Contouring • Receive, transmit, store, retrieve, display, and process medical images and DICOM objects

Source page: https://510kreport.com/device/K242994
Methodology: https://510kreport.com/methodology