510(k) K261288 ยท IYN System, Imaging, Pulsed Doppler, Ultrasonic
Handheld Ultrasound Scanner
| Applicant | IMGFAX CO., LTD., Foshan, CN |
| Decision | Substantially Equivalent, Jul 30, 2026 |
| Received | Apr 20, 2026 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K261288
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.