510(k) K260313 ยท IYO System, Imaging, Pulsed Echo, Ultrasonic
MD-6000S Bladder Scanner
| Applicant | MEDA Co., Ltd., Tianjin, CN |
| Decision | Substantially Equivalent, Sep 24, 2026 |
| Received | Jan 30, 2026 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K260313
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.