Transparency Registry · K212624
EFAI Intelligent Cardiothoracic Ratio (iCTR) Assessment System
Ever Fortune.Ai, Co., Ltd. · cleared 2022-04-04 under product code QIH (Automated Radiological Image Processing Software).
The public record
| 510(k) number | K212624 (FDA database) |
| Device name as cleared | EFAI Intelligent Cardiothoracic Ratio (iCTR) Assessment System |
| Applicant | Ever Fortune.Ai, Co., Ltd. (Taichung City, TW) |
| Decision | Substantially Equivalent · Traditional pathway |
| Decision date | 2022-04-04 |
| FDA product code | QIH — Automated Radiological Image Processing Software |
| Review panel | Radiology |
Source: openFDA 510(k) records, stored verbatim. Entry added 2026-08-29; the source link above is authoritative if any discrepancy exists.
Public disclosure beyond the clearance
| FDA clearance record | Located — linked above |
| Public model card / intended-use document | Not yet located in public sources |
| Peer-reviewed validation publication | Not yet located in public sources |
| Published subgroup / equity performance | Not yet located in public sources |
| Public monitoring or update commitments | Not yet located in public sources |
"Not yet located" is a statement about what we could find in public sources — not a statement about the product or whether such materials exist privately. Vendors: these rows update free of charge on submission of a public link — start here.
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