X9 Ultrasound System is an AI-enabled medical device from X9, Inc., listed by FDA (510(k), K251673) with a decision date of 2025-10-17. Review panel: Radiology.
| FDA submission number | K251673 |
|---|---|
| Pathway | 510(k) |
| Company | X9, Inc. |
| Review panel (specialty) | Radiology |
| FDA decision date | 2025-10-17 |
| Decision | Substantially Equivalent |
| Product code | SGH |
| Classification | Ultrasound Imaging For Vascular Access For Hemodialysis |
| Device class | 2 |
| Regulation number | 892.1560 |
| Review time (calendar days) | 140 |
| Applicant country | US |
Official FDA database record · FDA AI-enabled device list
All Radiology AI devices · Full device index
Data from FDA's AI-enabled device list and openFDA. Informational only; verify against the FDA record.