# K251306: Seg Pro V3 (RT-300)

- Pathway: 510(k) (Traditional)
- Applicant: Ever Fortune.Ai, Co., Ltd.
- Decided: Jan 28, 2026 after 275 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 K954874 (1996). 103 ancestors in all.
No later device cites it as a predicate yet.
1 of 104 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K231928: EFAI RTSUITE CT HCAP-Segmentation System, Ever Fortune.Ai, Co., Ltd. (2023) Summary page 5.

## Indications for use
Seg Pro V3 is a software device intended to assist trained radiation oncology professionals, including, but not limited to, radiation oncologists, medical physicists, and dosimetrists, during their clinical workflows of radiation therapy treatment planning by providing initial contours of organs at risk on DICOM images. Seg Pro V3 is intended to be used on adult patients only. The contours are generated by deep-learning algorithms and then transferred to radiation therapy treatment planning systems. Seg Pro V3 must be used in conjunction with a DICOM-compliant treatment planning system to review and edit results generated. Seg Pro V3 is not intended to be used for decision making or to detect lesions. Seg Pro V3 is an adjunct tool and is not intended to replace a clinician's judgment and manual contouring of the normal organs on DICOM images. Clinicians must not use the software generated output alone without review as the primary interpretation.

Source page: https://510kreport.com/device/K251306
Methodology: https://510kreport.com/methodology