510(k) K250030 ยท IYN System, Imaging, Pulsed Doppler, Ultrasonic
Flash Ultrasound System 5100 Point of Care
| Applicant | Philips Ultrasound, LLC, Bothell WA, US |
| Decision | Substantially Equivalent, Apr 28, 2025 |
| Received | Jan 6, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K250030
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 22, 2025 | Philips Ultrasound, Inc eL18-4 Transducer Probe Open, Classified |
IYN | None listed |
| Aug 22, 2025 | Philips Ultrasound, Inc mL26-8 Transducer Probe Open, Classified |
IYN | None listed |
| Aug 22, 2025 | Philips Ultrasound, Inc X8-2t Transducer Probe Open, Classified |
IYN | None listed |
| Aug 22, 2025 | Philips Ultrasound, Inc XL14-3 Transducer Probe Open, Classified |
IYN | None listed |
| Jul 2, 2025 | Philips Ultrasound, Inc Philips XL14-3 Transducer. Open, Classified |
ITX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.