510(k) K081802 ยท ITX Transducer, Ultrasonic, Diagnostic
CX50 DIAGNOSTIC ULTRASOUND SYSTEM
| Applicant | Philips Ultrasound, Inc., Bothell WA, US |
| Decision | Substantially Equivalent, Jul 11, 2008 |
| Received | Jun 26, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K081802
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 22, 2025 | Philips Ultrasound, Inc D2cwc Transducer Probe Open, Classified |
IYN | None listed |
| Aug 22, 2025 | Philips Ultrasound, Inc X7-2t Transducer Probe Open, Classified |
IYN | None listed |
| Jul 2, 2025 | Philips Ultrasound, Inc Philips S5-1 Transducer. Open, Classified |
ITX | None listed |
| Jul 2, 2025 | Philips Ultrasound, Inc Philips X7-2t 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.