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SGH — Ultrasound Imaging For Vascular Access For Hemodialysis Class II

FDA Device Classification

Classification Details

Product Code: SGH
Device Class: Class II
Regulation Number: 892.1560
Submission Type
Review Panel: GU
Medical Specialty: Radiology
Implant: No

Definition

Ultrasound imaging for vascular access for hemodialysis

Recent 510(k) Clearances

K-Number	Applicant	Device Name	Date
K251673	x9	X9 Ultrasound System	October 17, 2025