SGH — Ultrasound Imaging For Vascular Access For Hemodialysis Class II
FDA product code SGH covers "Ultrasound Imaging For Vascular Access For Hemodialysis", a Class II medical device regulated under 21 CFR 892.1560. Submissions are reviewed by the Radiology panel. At least 1 recent 510(k) clearance has been granted under this product code.
Classification Details
- Product Code
- SGH
- Device Class
- Class II
- Regulation Number
- 892.1560
- Submission Type
- Review Panel
- GU
- Medical Specialty
- Radiology
- Implant
- No
Definition
Ultrasound imaging for vascular access for hemodialysis
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K251673 | X9 | X9 Ultrasound System | Oct 17, 2025 |