FDA-cleared K251673
X9 Ultrasound System
X9, Inc.
Authorized purpose: X9 Ultrasound System provides ultrasound imaging of validated vascular access for hemodialysis during the preliminary stage before needle insertion; a qualified healthcare professional confirms position using standard-of-care methods.
- Modality
- Ultrasound
- Anatomy
- Vascular accesses for hemodialysis
- Decision
- 2025-10-17