SGH

Ultrasound Imaging For Vascular Access For Hemodialysis

Product code
SGH
Device name
Ultrasound Imaging For Vascular Access For Hemodialysis
Device class
Class 2
21 CFR
21 CFR 892.1560
Medical specialty
Radiology
Marketing pathway
510(K)
510(k) clearances (last 3 years)
1
Summaries archived here
1 (direct download)
510(k) clearances (all years, FDA)
1 (all years; only the last 3 years are listed here)

FDA classification definition

Ultrasound imaging for vascular access for hemodialysis

Definition text from the FDA device classification database (U.S. federal government work, public domain).

510(k) clearances, last 3 years (1)

Last three years. Most recent: 2025-10-17.

NumberDecision dateApplicantDevice nameSummary
K2516732025-10-17X9, Inc.X9 Ultrasound SystemPDF

1 summaries are archived here for direct download.

Official FDA classification page: SGH
Classification and pathway per current FDA publications. Data from openFDA (CC0).