510(k) K253595 ยท IYN System, Imaging, Pulsed Doppler, Ultrasonic
EPIQ Series Diagnostic Ultrasound System, Affiniti Series Diagnostic Ultrasound System
| Applicant | Philips Ultrasound, LLC, Bothell WA, US |
| Decision | Substantially Equivalent, Mar 27, 2026 |
| Received | Nov 18, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K253595
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.