510(k) K250791 ยท IYN System, Imaging, Pulsed Doppler, Ultrasonic
ASUS Ultrasound Imaging System (LU800 series)
| Applicant | Asustek Computer, Inc., Taipei, TW |
| Decision | Substantially Equivalent, Dec 4, 2025 |
| Received | Mar 14, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K250791
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.