Radiology · 510(k) · 2025
X9 Ultrasound System
X9, Inc.. Cleared by FDA on 17 October 2025 under submission K251673, product code SGH (ultrasound imaging for vascular access for hemodialysis). What FDA's record says, in FDA's words.
Device record · K251673
- Device. X9 Ultrasound SystemDEVICE
- Company. X9, Inc.COMPANY
- Decision. 17 October 2025, 510(k), substantially equivalent (traditional review); received 30 May 2025DECISION
- Panel. RadiologyPANEL
- Product code. SGH, Ultrasound Imaging For Vascular Access For HemodialysisCODE
- Regulation. 21 CFR 892.1560, Class IIREG
- Source. FDA database entry · decision document (8 pages)SOURCE
Retrieved · the fields above are FDA's; the statement below was copied from the decision document on that day.
What FDA cleared it for
The Indications for Use statement, verbatim, from the decision document.
The X9 Ultrasound System is intended for ultrasound imaging of validated vascular accesses for hemodialysis during the preliminary stage of a cannulation procedure, prior to inserting the needle. The device is intended to be used by qualified healthcare professionals in a medical setting. The device is not intended to be used to diagnose the position of the vascular access without confirming position per standard of care. The X9 Ultrasound System is not for use in pediatric patients.
The product code's definition, from FDA's classification record. Ultrasound imaging for vascular access for hemodialysis
What the statement says
Pattern matches on the Indications for Use text. Each line is a fact that the text contains the words, not a finding about the device.
- Modalities namedultrasound
- Mentionspediatric patients
Adverse-event reports in MAUDE, by product code
As of , MAUDE held 0 reports filed against devices carrying product code SGH. That code is shared by every device of this type, not this device alone, and MAUDE reports are submitted by manufacturers, facilities and the public without FDA verification.
Where this fits
This page is a record, not medical advice and not a safety rating. It copies FDA's fields and FDA's statement, and lists what the statement's text mentions. Read the labeling before relying on any of it.
More devices under product code SGH, in Radiology, or cleared in 2025. The whole record is at FDA AI-enabled medical devices.
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