510(k) K251673
- Device
- X9 Ultrasound System
- Applicant
- X9, Inc.
- 510(k) number
- K251673
- Product code
- SGH
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2025-10-17
- Date received
- 2025-05-30
- Regulation
- 892.1560
- Classification name
- Ultrasound Imaging For Vascular Access For Hemodialysis
- Medical specialty
- Radiology
- Review panel
- Radiology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- N
Related Records
Applicant Contact
- Contact
- Melissa Viotti
- Address
- 10 Research Pkwy., Suite 350 Wallingford CT US 06492 06492
FDA Registration Numbers
- 3042470731