510(k) K042540 ยท IYO System, Imaging, Pulsed Echo, Ultrasonic
PHILIPS IU22 ULTRASOUND SYSTEM
| Applicant | Philips Ultrasound, Inc., Bothell WA, US |
| Decision | Substantially Equivalent, Oct 4, 2004 |
| Received | Sep 20, 2004 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K042540
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 24, 2026 | Philips Ultrasound, Inc Philips X3-1 Ultrasound Transducer Open, Classified |
ITX | None listed |
| Aug 22, 2025 | Philips Ultrasound, Inc X3-1 Transducer Probe Open, Classified |
IYN | None listed |
| Jul 2, 2025 | Philips Ultrasound, Inc Philips S5-1 Transducer. Open, Classified |
ITX | None listed |
| Sep 6, 2023 | Philips Ultrasound, Inc. 3D9-3v Transducer, accessory to Philips Ultrasound Systems: EPIQ Elite; Affiniti 30, 50, and 70; ClearVue 850; HD15; iU22; and Compact 5000 Completed |
ITX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.