510(k) K203406 ยท IYN System, Imaging, Pulsed Doppler, Ultrasonic
Lumify Diagnostic Ultrasound System
| Applicant | Philips Ultrasound, Inc., Bothell WA, US |
| Decision | Substantially Equivalent, Feb 23, 2021 |
| Received | Nov 19, 2020 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K203406
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 4, 2025 | Philips Ultrasound, LLC Lumify Diagnostic Ultrasound System models : 795005, 795161, 989605449841, 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 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.