510(k) K120321 ยท IYN System, Imaging, Pulsed Doppler, Ultrasonic
CLEARVUE 350/550 DIAGNOSTIC ULTRASOUND SYSTEM
| Applicant | Philips Health Care, Andover MA, US |
| Decision | Substantially Equivalent, Feb 17, 2012 |
| Received | Feb 2, 2012 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K120321
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 24, 2026 | Philips Ultrasound, Inc Philips S4-1 Ultrasound Transducer Open, Classified |
ITX | None listed |
| Aug 22, 2025 | Philips Ultrasound, Inc C5-2 Transducer Probe Open, Classified |
IYN | None listed |
| Aug 22, 2025 | Philips Ultrasound, Inc C9-4v Transducer Probe Open, Classified |
IYN | None listed |
| Aug 22, 2025 | Philips Ultrasound, Inc L12-4 Transducer Probe Open, Classified |
IYN | None listed |
| Aug 22, 2025 | Philips Ultrasound, Inc S4-1 Transducer Probe Open, Classified |
IYN | None listed |
| Jul 2, 2025 | Philips Ultrasound, Inc Philips C5-2 Transducer. Open, Classified |
ITX | None listed |
| Jul 2, 2025 | Philips Ultrasound, Inc Philips L12-4 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.