All AI devices
EmergencyUS

EFAI Chestsuite XR Malpositioned ETT Assessment System (ETT-XR-100)

Ever Fortune.Ai, Co., Ltd. · Triage & notification (CADt)

What it does

Scans multi-modality studies for suspected time-critical findings and moves those cases up the reading worklist so they are seen sooner. It reprioritizes — it does not diagnose.

Who it's for

On-call, emergency, and teleradiology readers and high-volume centers that want faster turnaround on critical findings.

Reported performance

No sensitivity / specificity / AUC was disclosed in the available summary. Many summaries report no standalone metrics — we note that honestly rather than imply a number.

Performance numbers are manufacturer-reported and often single-site; treat them as a starting point, not an independent benchmark.

FDA

Pathway510(k)
Submission #K242821
Product codeQAS
Decision dateFeb 20, 2025
PanelRadiology
FDA recordaccessdata

EU (CE)

Statusunknown
Risk class
Notified body
EMDN code
Basic UDI-DI
AI Act class

EU coverage is filling out through 2026; absence here doesn't mean a device isn't CE-marked.

Vendor

Foundedunknown

Cite this page

RadPigeon. "EFAI Chestsuite XR Malpositioned ETT Assessment System (ETT-XR-100) (Ever Fortune.Ai, Co., Ltd.)." AI Devices registry. https://radpigeon.news/ai/device/efai-chestsuite-xr-malpositioned-ett-assessment-system-ett-xr-100

Last updated Jun 29, 2026. Information only — not clinical advice. Summaries are RadPigeon's own wording.