1 device · 1 company · 2025
Product code SGH: Ultrasound Imaging For Vascular Access For Hemodialysis
1 device under product code SGH, 2025, from 1 company. Each record carries FDA's decision, the Indications for Use statement verbatim where the public document carries one (1 of 1 here), the regulation, and MAUDE report counts by product code.
Ultrasound Imaging For Vascular Access For Hemodialysis. 21 CFR 892.1560, Class II. Ultrasound imaging for vascular access for hemodialysis MAUDE held 0 adverse-event reports against this product code as of 2026-10-29; reports are unverified and the code is shared by every device of this type.
Retrieved from FDA public records.
Every device, newest decision first
| Decision | Device | Company | Panel | FDA |
|---|---|---|---|---|
| X9 Ultrasound SystemK251673 · 510(k) | X9, Inc. | Radiology | database entry |
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