510(k) K111513 ยท IYN System, Imaging, Pulsed Doppler, Ultrasonic
CX50 DIAGNOSTIC ULTRASOUND SYSTEM
| Applicant | Philips Ultrasound, Inc., Andover MA, US |
| Decision | Substantially Equivalent, Jun 24, 2011 |
| Received | Jun 1, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K111513
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 22, 2025 | Philips Ultrasound, Inc c5-1 Transducer Probe Open, Classified |
IYN | None listed |
| Aug 22, 2025 | Philips Ultrasound, Inc C9-3v Transducer Probe Open, Classified |
IYN | None listed |
| Aug 22, 2025 | Philips Ultrasound, Inc D2cwc Transducer Probe Open, Classified |
IYN | None listed |
| Aug 22, 2025 | Philips Ultrasound, Inc D5cwc Transducer Probe Open, Classified |
IYN | None listed |
| Aug 22, 2025 | Philips Ultrasound, Inc L12-3 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 C5-1 Transducer. Open, Classified |
ITX | None listed |
| Jul 2, 2025 | Philips Ultrasound, Inc Philips L12-3 Transducer. Open, Classified |
ITX | 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.