510(k) K243226 ยท IYN System, Imaging, Pulsed Doppler, Ultrasonic
Ultrasound Imaging System (LU700 Series); Ultrasound Imaging System (128 Series); Ultrasound Imaging System (LX Series)
| Applicant | Leltek, Inc., New Taipei City, TW |
| Decision | Substantially Equivalent, May 8, 2025 |
| Received | Oct 8, 2024 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K243226
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.