Clearance Summary
EFAI Intelligent Cardiothoracic Ratio (iCTR) Assessment System received FDA 510(k) clearance under submission number K212624, sponsored by Ever Fortune.Ai, Co., Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 2022-04-04.
- Submission: K212624
- Applicant / Sponsor: Ever Fortune.Ai, Co., Ltd.
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.2050
- Decision date: 2022-04-04
Classification & Regulation
This clearance is catalogued under FDA product code QIH and 21 CFR 892.2050, within the Radiology review panel as a Class II device.