510(k) K093563 ยท IYN System, Imaging, Pulsed Doppler, Ultrasonic
IU22 ULTRASOUND SYSTEM AND TRANSDUCERS
| Applicant | Philips Ultrasound, Inc., Bothell WA, US |
| Decision | Substantially Equivalent, Feb 1, 2010 |
| Received | Nov 18, 2009 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K093563
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 24, 2026 | Philips Ultrasound, Inc Philips L12-5 Ultrasound Transducer Open, Classified |
ITX | None listed |
| Aug 22, 2025 | Philips Ultrasound, Inc L12-5 50 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.