EFAI RTSuite CT HN-Segmentation System
K220264Ever Fortune.AI Co., Ltd. · cleared 2022-04-28 · product code QKB · Radiology
Premarket evidence — what FDA accepted
source quote (p.5)
“EFAI RTSuite CT HN-Segmentation System, herein referred to as EFAI HNSeg, is a standalone software that is designed to be used by trained radiation oncology professionals to automatically delineate head-and-neck organs-at-risk (OARs) on CT images.”
source quote (p.5)
“The contours are generated by deep-learning algorithms and then transferred to radiation therapy treatment planning systems.”
source quote (p.7)
“Additionally, the software validation activities were performed in accordance with IEC 62304:2006/A1:2016 - Medical device software – Software life cycle processes, in addition to the FDA Guidance documents, “Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices”(2005) and the recently published “Content of Premarket submissions for Devices Software Functions (11-04-2021), and “Content of Premarket Submission for Management of Cybersecurity in Medical Devices.””
Validation studies (1)
Retrospective clinical
sample size not stated
endpoints: mean Dice coefficient
standards: IEC 62304:2006/A1:2016 - Medical device software – Software life cycle processes, Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices”(2005), Content of Premarket submissions for Devices Software Functions (11-04-2021), Content of Premarket Submission for Management of Cybersecurity in Medical Devices.
Reported performance (1 observation)
source quote (p.7)
“The results demonstrate that the EFAI HNSeg device was non-inferior to the predicate by at least a non-inferiority limit of 0.1 Dice, which was the largest difference that is clinically acceptable based on previous studies, and thus we conclude that equivalence has been demonstrated.”
Each value carries its own analysis unit and task — never compare or pool across devices. Source: 510(k) summary PDF.
Predicate network
Postmarket — what happened after clearance
- re_clearance
The FDA AI/ML device list shows a newer 510(k) K231928 (decision 2023-09-25) from Ever Fortune.AI Co., Ltd. for a matching device line ("EFAI RTSUITE CT HCAP-Segmentation System") — a new clearance for the same line is a change event.
first seen 2026-07-08 · k_number:K231928
Recall and MAUDE counts are product-code-level (reports aren't reliably attributable to one device). Signals are descriptive observables with sources — never a judgment that the device is unsafe or drifting. Snapshot 2026-07-08.
Reimbursement — how devices like this got paid
Not yet tracked — no payment pathway indexed for this clearance (the reimbursement corpus is a growing seed set).