K251673
- 510(k) number
- K251673
- Device name
- X9 Ultrasound System
- Applicant
- X9, Inc. CT · US
- Product code
- SGH — Ultrasound Imaging For Vascular Access For Hemodialy
- Decision date
- 2025-10-17
- Date received
- 2025-05-30
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 2.5 MB · U.S. public domain
Also available from FDA: K251673.pdf
Official FDA record: K251673
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.