510(k) K130499 ยท IYN System, Imaging, Pulsed Doppler, Ultrasonic
IU22 DIAGNOSTIC ULTRASOUND SYSTEM
| Applicant | Philips Ultrasound, Inc., Bothell WA, US |
| Decision | Substantially Equivalent, Jun 18, 2013 |
| Received | Feb 26, 2013 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K130499
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 22, 2025 | Philips Ultrasound, Inc c5-1 Transducer Probe Open, Classified |
IYN | None listed |
| Jul 2, 2025 | Philips Ultrasound, Inc Philips C5-1 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.