EFAI ChestSuite XR Pneumothorax Assessment System is an AI-enabled medical device from Ever Fortune AI Co., Ltd., listed by FDA (510(k), K221552) with a decision date of 2022-11-08. Review panel: Radiology.
| FDA submission number | K221552 |
|---|---|
| Pathway | 510(k) |
| Company | Ever Fortune AI Co., Ltd. |
| Review panel (specialty) | Radiology |
| FDA decision date | 2022-11-08 |
| Decision | Substantially Equivalent |
| Product code | QFM |
| Classification | Radiological Computer-Assisted Prioritization Software For Lesions |
| Device class | 2 |
| Regulation number | 892.2080 |
| Review time (calendar days) | 161 |
| Applicant country | TW |
Official FDA database record · FDA AI-enabled device list
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Data from FDA's AI-enabled device list and openFDA. Informational only; verify against the FDA record.