EFAI RTSuite CT HN-Segmentation System

K220264

Ever Fortune.AI Co., Ltd. · cleared 2022-04-28 · product code QKB · Radiology

Premarket evidence — what FDA accepted

Device typesamd
source quote (p.3)
“EFAI HNSeg 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 CT images.”
AlgorithmDeep learning
source quote (p.3)
“The contours are generated by deep-learning algorithms and then transferred to radiation therapy treatment planning systems.”
Adaptive (vs locked)FDA source did not state this
PCCPNo
Cybersecurity addressedYes
source quote (p.7)
“and “Content of Premarket Submission for Management of Cybersecurity in Medical Devices.””

Validation studies (1)

Standalone

sample size not stated

endpoints: non-inferiority limit of 0.1 Dice

standards: IEC 62304:2006/A1:2016, 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)

diceas written: “Dice coefficient (non-inferiority)”stated without value
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

0
recalls in product code, 24mo
0
MAUDE reports in code, 12mo
—
vs code's own 3-yr baseline
1
drift signals on this device
  • 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); a recall is shown as device-attributed only when the recall record itself lists this clearance number. 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).

Applicable FDA guidance — what the submission is measured against

FDA guidance documents and guiding principles applicable to 510(k) AI/ML devices in the Radiology panel. A curated reference index, not legal or regulatory advice — each item states its own status, and a draft is never binding.

Applicability is derived from the device's FDA advisory panel and pathway — cross-cutting guidances apply to every AI/ML device; panel-specific ones are flagged. Titles, dates, and links verified against fda.gov as of July 2026.

Constat Precedent · public FDA/CMS data · descriptive decision-support, not regulatory or reimbursement advice. Share this page: constat.dev/precedent/device/K220264