# K220264: EFAI RTSuite CT HN-Segmentation System

- Pathway: 510(k) (Traditional)
- Applicant: Ever Fortune.Ai, Co., Ltd.
- Decided: Apr 28, 2022 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: 15 generations back to K954874 (1996). 101 ancestors in all.
2 later devices descend 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)
- K191928: AccuContour, Xiamen Manteia Technology, Ltd. (2020) Summary page 4.

## Most influential descendants
- K231928: EFAI RTSUITE CT HCAP-Segmentation System (2023), 1 descendant of its own
- K251306: Seg Pro V3 (RT-300) (2026), 0 descendants of its own

## Indications for use
EFATTINSeg 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 in the head and neck region on non-contrast C'1" images. EFAI HNSeg 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. EFAT HNSeg must be used in conjunction with a DICOM-compliant treatment planning system to review and edit results generated. EFAI HNSeg is not intended to be used for decision making or to detect lesions. EFAI HNSeg 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/K220264
Methodology: https://510kreport.com/methodology