510(k) K233545 ยท IYN System, Imaging, Pulsed Doppler, Ultrasonic
EPIQ Series Diagnostic Ultrasound System
| Applicant | Philips Ultrasound, LLC, Bothell WA, US |
| Decision | Substantially Equivalent, Nov 30, 2023 |
| Received | Nov 3, 2023 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K233545
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 22, 2025 | Philips Ultrasound, Inc X11-4t Transducer Probe Open, Classified |
IYN | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.