# K231928: EFAI RTSUITE CT HCAP-Segmentation System

- Pathway: 510(k) (Special)
- Applicant: Ever Fortune.Ai, Co., Ltd.
- Decided: Sep 25, 2023 after 87 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 K954874 (1996). 102 ancestors in all.
1 later device descends from it; 1 cites it directly.
1 of 104 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K220264: EFAI RTSuite CT HN-Segmentation System, Ever Fortune.Ai, Co., Ltd. (2022) Summary page 4.

## Most influential descendants
- K251306: Seg Pro V3 (RT-300) (2026), 0 descendants of its own

## Indications for use
EFAI HCAPSeg 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 non-contrast CT images. EFAI HCAPSeg 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. EFAI HCAPSeg must be used in conjunction with a DICOM-compliant treatment planning system to review and edit results generated. EFAI HCAPSeg is not intended to be used for decision making or to detect lesions. EFAI HCAPSeg is an adjunct tool and is not intended to replace a clinician's judgment and manual contouring of the normal organs on CT. Clinicians must not use the software generated output alone without review as the primary interpretation.

Source page: https://510kreport.com/device/K231928
Methodology: https://510kreport.com/methodology