510(k) K250331 ยท IYO System, Imaging, Pulsed Echo, Ultrasonic
Astrasono A3Pro Bladder Scanner (A3Pro)
| Applicant | Astrasono Technology Co., Ltd., Shenzhen, CN |
| Decision | Substantially Equivalent, Sep 30, 2025 |
| Received | Feb 5, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K250331
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.