X9 Ultrasound System— 510(k) K251673
Substantially EquivalentX9, Inc.
FDA 510(k) clearance K251673 for X9 Ultrasound System, Substantially Equivalent on 2025-10-17. Applicant: X9, Inc.. Device class: 2.
Clearance details
- Applicant
- X9, Inc.
- Product code
- Code SGH
- Device class
- Class 2
- Regulation
- 21 CFR 892.1560
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Wallingford, CT, US
Data sourced from openFDA. This site is unofficial and independent of the FDA.