510(k) K163020 ยท IYN System, Imaging, Pulsed Doppler, Ultrasonic
Xperius Ultrasound System
| Applicant | Philips Health Care, Bothell WA, US |
| Decision | Substantially Equivalent, Nov 16, 2016 |
| Received | Oct 31, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K163020
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 2, 2025 | Philips Ultrasound, Inc Philips L12-4 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.