510(k) K253714 ยท IYO System, Imaging, Pulsed Echo, Ultrasonic
IntraSight Plus
| Applicant | Philips Image Guided Therapy Corporation, Colorado Springs CO, US |
| Decision | Substantially Equivalent, Feb 24, 2026 |
| Received | Nov 24, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K253714
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 25, 2026 | Volcano Corp Philips IntraSight Plus
REF: 797423 and 797417
100-120v-220-240v,50/60hZ, 1000 VA Open, Classified |
IYO | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.