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510(k) K251673

X9 Ultrasound System by X9, Inc. — Product Code SGH

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: October 17, 2025
Date Received: May 30, 2025
Clearance Type: Traditional
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Ultrasound Imaging For Vascular Access For Hemodialysis
Device Class: Class II
Regulation Number: 892.1560
Review Panel: GU
Submission Type

Ultrasound imaging for vascular access for hemodialysis