510(k) K251673
K251673 is an FDA 510(k) premarket notification submitted by X9, Inc. for the device "X9 Ultrasound System". The FDA issued a decision of Substantially Equivalent on Oct 17, 2025. The device falls under product code SGH (Ultrasound Imaging For Vascular Access For Hemodialysis), a Class II device regulated under 21 CFR 892.1560.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Oct 17, 2025
- Date Received
- May 30, 2025
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Ultrasound Imaging For Vascular Access For Hemodialysis
- Device Class
- Class II
- Regulation Number
- 892.1560
- Review Panel
- GU
- Submission Type
Ultrasound imaging for vascular access for hemodialysis