510(k) K243794 ยท IYN System, Imaging, Pulsed Doppler, Ultrasonic
EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound System
| Applicant | Philips Ultrasound, LLC, Bothell WA, US |
| Decision | Substantially Equivalent, Feb 6, 2025 |
| Received | Dec 10, 2024 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K243794
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.