DeviceClearance

Product code SGH— Radiology

X9 Ultrasound System

Classification name
Ultrasound Imaging For Vascular Access For Hemodialysis
Device class
Class 2
Regulation
21 CFR 892.1560
Advisory panel
Radiology
Total cleared
1
First cleared
Most recent

FDA classification definition

“Ultrasound imaging for vascular access for hemodialysis”

— U.S. Food and Drug Administration, device classification record for product code SGH under 21 CFR 892.1560, via openFDA

Market context for product code SGH

FDA has cleared 1 device under product code SGH, all in 2025, filed by 1 applicant company. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Top applicants under product code SGH

Recent clearances under product code SGH

Data sourced from openFDA. This site is unofficial and independent of the FDA.