X9 Ultrasound System
FDA 510(k) clearance K251673 · decided 2025-10-17
Clearance details
- K-number
- K251673
- Device name
- X9 Ultrasound System
- Applicant
- X9, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2025-05-30
- Decision date
- 2025-10-17
- Days to decision
- 140 days
- Clearance type
- Traditional
- Product code
- SGH
- Device class
- 2
- Regulation number
- 892.1560
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Wallingford, CT, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.