510(k) K222648 ยท IYN System, Imaging, Pulsed Doppler, Ultrasonic
5000 Compact Series Ultrasound Systems (Ultrasound System 5500 G, Ultrasound System 5500 P, Ultrasound System 5500 W, Ultrasound System 5500 CV, Ultrasound System 5300 G, Ultrasound System 5300 P, Ultrasound System 5300 W)
| Applicant | Philips Ultrasound, LLC, Bothell WA, US |
| Decision | Substantially Equivalent, Sep 27, 2022 |
| Received | Sep 1, 2022 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K222648
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 3, 2024 | Philips Ultrasound, Inc. 5000 Compact Series Ultrasound Systems, Product/REF: 5500 CV/795141, 5500 P/795143, 5500 W/795144, 5500 G/795145, and Product/REF: 5300 W/795146, 5300 P/795147, 5300 G/795148, used with Deluxe and Pre Open, Classified |
IYN | 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.