510(k) K152899 ยท IYN System, Imaging, Pulsed Doppler, Ultrasonic
Philips Lumify Diagnostic Ultrasound System
| Applicant | Philips Healthcare, Inc., Bothell WA, US |
| Decision | Substantially Equivalent, Oct 30, 2015 |
| Received | Oct 1, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K152899
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| 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 |
| Jan 6, 2016 | Philips Ultrasound, Inc. Philips Lumify Diagnostic Ultrasound, Catalogue Number: 795216
Part Number: 989605449841 with 453561845331 (software version 1.0) Terminated |
IYN | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.