K250331
- 510(k) number
- K250331
- Device name
- Astrasono A3Pro Bladder Scanner (A3Pro)
- Applicant
- Astrasono Technology Co., Ltd. CN
- Product code
- IYO — System, Imaging, Pulsed Echo, Ultrasonic
- Decision date
- 2025-09-30
- Date received
- 2025-02-05
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 1.0 MB · U.S. public domain
Also available from FDA: K250331.pdf
Official FDA record: K250331
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.