Acclarix AX8 Series Diagnostic Ultrasound System (Model: Acclarix AX7, Acclarix AX8, Accla — Edan Instruments, Inc. (510(k) K25021
Acclarix AX8 Series Diagnostic Ultrasound System (Model: Acclarix AX7, Acclarix AX8, Accla — Edan Instruments, Inc. (510(k) K25021 is one of 9,000 device clearances in the DeviceClear dataset. Key details — Device name: Acclarix AX8 Series Diagnostic Ultrasound System (Model: Acclarix AX7, Acclarix AX8, Accla; Applican
| Device name | Acclarix AX8 Series Diagnostic Ultrasound System (Model: Acclarix AX7, Acclarix AX8, Accla |
|---|---|
| Applicant | Edan Instruments, Inc. |
| Clearance track | 510(k) |
| Submission number | K250214 |
| Decision | Substantially Equivalent |
| Decision date | 2025-02-20 |
| Date received | 2025-01-24 |
| Product code | IYN |
| Device class | 2 |
| Medical specialty | Radiology |
| Applicant location | CN |
| Source | openFDA device |
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$1999/mo
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