K251673 is an FDA 510(k) clearance for the X9 Ultrasound System. This device is classified as a Ultrasound Imaging For Vascular Access For Hemodialysis (Class II - Special Controls, product code SGH).
Submitted by X9, Inc. (Wallingford, US). The FDA issued a Cleared decision on October 17, 2025, 140 days after receiving the submission on May 30, 2025.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 892.1560. Ultrasound Imaging For Vascular Access For Hemodialysis.
| 510(k) Number | K251673 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 30, 2025 |
| Decision Date | October 17, 2025 |
| Days to Decision | 140 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | SGH - Ultrasound Imaging For Vascular Access For Hemodialysis |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.1560 |
| Definition | Ultrasound Imaging For Vascular Access For Hemodialysis |