# K251673: X9 Ultrasound System

- Pathway: 510(k) (Traditional)
- Applicant: X9, Inc.
- Decided: Oct 17, 2025 after 140 days
- Product code: SGH (Ultrasound Imaging For Vascular Access For Hemodialysis)
- Device class: 2
- Regulation: 21 CFR 892.1560
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 11 generations back to K945773 (1995). 43 ancestors in all.
No later device cites it as a predicate yet.
0 of 44 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K211193: BD Prevue II Peripheral Vascular Vascular Access System, Bard Access Systems, Inc. (C.R. Bard, Inc.) (2021) Summary page 5.

## Indications for use
The X9 Ultrasound System is intended for ultrasound imaging of validated vascular accesses for hemodialysis during the preliminary stage of a cannulation procedure, prior to inserting the needle. The device is intended to be used by qualified healthcare professionals in a medical setting. The device is not intended to be used to diagnose the position of the vascular access without confirming position per standard of care. The X9 Ultrasound System is not for use in pediatric patients.

Source page: https://510kreport.com/device/K251673
Methodology: https://510kreport.com/methodology