510(k) K261211 ยท IYN System, Imaging, Pulsed Doppler, Ultrasonic
Philips EPIQ Series Diagnostic Ultrasound System; Philips Affiniti Series Diagnostic Ultrasound System
| Applicant | Philips Ultrasound, LLC, Bothell WA, US |
| Decision | Substantially Equivalent, Jul 27, 2026 |
| Received | Apr 14, 2026 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K261211
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.