SGH
1 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Ultrasound Imaging For Vascular Access For Hemodialysis
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 892.1560
- Medical specialty
- Radiology
- FDA definition
- Ultrasound imaging for vascular access for hemodialysis
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| X9 Ultrasound System (K251673) | X9, Inc. | 2025-10-17 |
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Every clearance here is in the API, with alerts when new ones post.