SGH
- Product code
- SGH
- Device name
- Ultrasound Imaging For Vascular Access For Hemodialysis
- Device class
- Class 2
- 21 CFR
- 21 CFR 892.1560
- Medical specialty
- Radiology
- Marketing pathway
- 510(K)
- 510(k) clearances (last 3 years)
- 1
- Summaries archived here
- 1 (direct download)
- 510(k) clearances (all years, FDA)
- 1 (all years; only the last 3 years are listed here)
FDA classification definition
Ultrasound imaging for vascular access for hemodialysis
510(k) clearances, last 3 years (1)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K251673 | 2025-10-17 | X9, Inc. | X9 Ultrasound System |
Official FDA classification page: SGH
Classification and pathway per current FDA publications. Data from openFDA (CC0).