510(k) K253487 ยท IYN System, Imaging, Pulsed Doppler, Ultrasonic
ACUSON Maple Diagnostic Ultrasound System; ACUSON Maple Select Diagnostic Ultrasound System
| Applicant | Siemens Medical Solutions USA, Inc., Issaquah WA, US |
| Decision | Substantially Equivalent, Nov 17, 2025 |
| Received | Oct 21, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K253487
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.