510(k) K252498 ยท IYN System, Imaging, Pulsed Doppler, Ultrasonic
Digital Color Doppler Ultrasound System (X11 Exp/X11 Elite/X11 Pro/X11 Plus/X11 Super/X11 Senior/X11/E11/E11 Pro/E11 Plus/E11 Elite/X11T/X11U/X11R/X11i/X11s/E11T/E11i/E11s/XR1/XR2/ XR3/ER1/ER2/ER3/X10 Exp/X10 Elite/X10 Pro/X10 Plus/X10 Super/X10 Senior/X10/X10T/X10U/ X10R/X10i/X10s/E10/E10 Pro/E10 P
| Applicant | Sonoscape Medical Corp., Shenzhen, CN |
| Decision | Substantially Equivalent, Dec 5, 2025 |
| Received | Aug 8, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K252498
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.