Product code SGH
- Device name
- Ultrasound Imaging For Vascular Access For Hemodialysis
- Medical specialty
- Radiology
- Device class
- 2
- Regulation number
- 892.1560
- Review panel
- GU
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Ineligible
- Definition
- Ultrasound imaging for vascular access for hemodialysis
- Source
- FDA openFDA device classification dataset
Related 510(k) Records
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K251673 | X9 Ultrasound System | X9, Inc. | 2025-10-17 |