Class Class II

EFAI Chestsuite XR Malpositioned ETT Assessment System (ETT-XR-100) (K242821)

K242821 2025-02-20 Traditional
Home/ Devices/ EFAI Chestsuite XR Malpositioned…

Description

EFAI Chestsuite XR Malpositioned ETT Assessment System (ETT-XR-100) by Ever Fortune.Ai, Co., Ltd., an FDA 510(k) cleared radiology device.

Regulatory Information

Device ClassClass Class II
510(k) NumberK242821
Clearance Date2025-02-20
Clearance TypeTraditional
Product CodeQAS
Regulation Number892.2080

Categories

Need More Information?

Contact the manufacturer or request a quote for this device.

Request Quote

Predicate lineage for K242821

A 510(k) clearance is granted by showing substantial equivalence to an earlier legally marketed device, called the predicate. This lineage is named in the 510(k) summary document and is not published by the FDA as a connected dataset. EFAI Chestsuite XR Malpositioned ETT Assessment System (ETT-XR-100) (K242821) cites 1 predicate device and is itself cited by 0 later devices.

Predicate devices cited by this clearance

Devices this clearance was compared against
K numberDeviceApplicantYear
K221330BriefCaseAidoc Medical , Ltd.2022

Trace the full predicate network for K242821

A link appears here only where the predicate could be read from a published 510(k) summary. Where no summary exists or a reference cannot be resolved to a K number, no link is drawn, so a gap means unknown rather than none.

Scroll to Top