Data / Medical devices / United States / X9 Inc.
X9 Inc.: FDA-registered device maker in Wallingford, CT, United States, 1 510(k) clearance
X9 Inc. is registered with the FDA (registration 3042470731) in Wallingford, CT, United States. It lists 4 device types. The FDA files 1 510(k) clearance under its listings, the newest dated October 17, 2025. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3042470731
- Address
- 10 Research Pkwy Ste 350, Wallingford, CT, United States, 06492
- Owner or operator
- X9 INC. (10094633)
- Roles
- Complaint file establishment, Manufacturer, Specification developer
- First device listed
- December 11, 2025
- Registered through
- 2026
- Brand names listed
- X9 Ultrasound System
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Automated Radiological Image Processing Software | QIH | 2 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| System, Imaging, Pulsed Echo, Ultrasonic | IYO | 2 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Transducer, Ultrasonic, Diagnostic | ITX | 2 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Ultrasound Imaging For Vascular Access For Hemodialysis | SGH | 2 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| October 17, 2025 | K251673 | X9 Ultrasound System | SGH | Substantially Equivalent | X9, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of System, Imaging, Pulsed Echo, Ultrasonic
- All makers of Automated Radiological Image Processing Software
- All makers of Transducer, Ultrasonic, Diagnostic
Updated October 17, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.