510(k) K162329 ยท IYN System, Imaging, Pulsed Doppler, Ultrasonic
CX50 Diagnostic Ultrasound System, Sparq Diagnostic Ultrasound System
| Applicant | Philips Health Care, Bothell WA, US |
| Decision | Substantially Equivalent, Sep 14, 2016 |
| Received | Aug 19, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K162329
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 22, 2025 | Philips Ultrasound, Inc C9-3io Transducer Probe Open, Classified |
IYN | None listed |
| Aug 22, 2025 | Philips Ultrasound, Inc L10-4LAP Transducer Probe Open, Classified |
IYN | None listed |
| Aug 30, 2019 | Philips Ultrasound Inc Transducer S7-3t
UDI (01)00884838061439
REF 989605406772
Can be used with: CX50, EPIQ 7, Affiniti 50 and Affiniti 70 Ultrasound systems - Product Usage: Diagnostic ultrasound imaging or fluid flow a Terminated |
ITX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.