510(k) K260680 ยท IYN System, Imaging, Pulsed Doppler, Ultrasonic
EPIQ Series Diagnostic Ultrasound Systems; Affiniti Series Diagnostic Ultrasound Systems
| Applicant | Philips Ultrasound, LLC, Bothell WA, US |
| Decision | Substantially Equivalent, May 27, 2026 |
| Received | Mar 2, 2026 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K260680
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 18, 2026 | Philips Ultrasound, LLC Philips EPIQ Elite Diagnostic Ultrasound System
Model # 795234 Open, Classified |
IYN | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.