510(k) K162549 ยท IYN System, Imaging, Pulsed Doppler, Ultrasonic
Lumify Ultrasound System
| Applicant | Philips Health Care, Bothell WA, US |
| Decision | Substantially Equivalent, Oct 3, 2016 |
| Received | Sep 13, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K162549
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 24, 2026 | Philips Ultrasound, Inc Philips S4-1 Ultrasound Transducer Open, Classified |
ITX | None listed |
| Aug 22, 2025 | Philips Ultrasound, Inc C5-2 Lumify Transducer Probe Open, Classified |
IYN | None listed |
| Aug 22, 2025 | Philips Ultrasound, Inc L12-4 Transducer Probe Open, Classified |
IYN | None listed |
| Aug 22, 2025 | Philips Ultrasound, Inc L12-4 Lumify Transducer Probe Open, Classified |
IYN | None listed |
| Aug 22, 2025 | Philips Ultrasound, Inc S4-1 Transducer Probe Open, Classified |
IYN | None listed |
| Aug 22, 2025 | Philips Ultrasound, Inc S4-1 Lumify 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.