Devices · X9, Inc.

X9 Ultrasound System

X9, Inc. is listed for X9 Ultrasound System (K251673). The FDA list gives October 17, 2025 as the date of the final decision. The lead panel is Radiology, and the database link on the FDA list is the 510(k) pathway. openFDA describes product code SGH as “Ultrasound Imaging For Vascular Access For Hemodialysis”: Ultrasound imaging for vascular access for hemodialysis openFDA records this submission’s decision description as “Substantially Equivalent.” This paragraph is assembled only from those public fields. It is not an FDA review, not a determination of safety or effectiveness, and not medical advice. Official record: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K251673

Official FDA database record

Date of final decision

October 17, 2025

Company on the FDA list

X9, Inc.

Lead panel

Radiology

Primary product code

SGH

openFDA device name for the code

Ultrasound Imaging For Vascular Access For Hemodialysis

Device class

2

Regulation number

892.1560

openFDA decision description

Substantially Equivalent

openFDA decision code

SESE

Statement or summary label

Summary