510(k) K163120 ยท IYN System, Imaging, Pulsed Doppler, Ultrasonic
EPIQ 5 Diagnostic Ultrasound System; EPIQ 7 Diagnostic Ultrasound System; Affiniti 50 Diagnostic Ultrasound System; Affiniti 70 Diagnostic Ultrasound System
| Applicant | Philips Ultrasound, Inc., Andover MA, US |
| Decision | Substantially Equivalent, Jan 10, 2017 |
| Received | Nov 8, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K163120
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 24, 2026 | Philips Ultrasound, Inc Philips Mini Multi TEE Ultrasound Transducer Open, Classified |
ITX | None listed |
| Mar 24, 2026 | Philips Ultrasound, Inc Philips X7-2 Ultrasound Transducer Open, Classified |
ITX | None listed |
| Aug 22, 2025 | Philips Ultrasound, Inc 3D9-3v Transducer Probe Open, Classified |
IYN | None listed |
| Aug 22, 2025 | Philips Ultrasound, Inc BP10-5ec Transducer Probe Open, Classified |
IYN | None listed |
| Aug 22, 2025 | Philips Ultrasound, Inc C10-3v Transducer Probe Open, Classified |
IYN | None listed |
| Aug 22, 2025 | Philips Ultrasound, Inc C10-4ec Transducer Probe Open, Classified |
IYN | None listed |
| Aug 22, 2025 | Philips Ultrasound, Inc C6-2 Transducer Probe Open, Classified |
IYN | None listed |
| Aug 22, 2025 | Philips Ultrasound, Inc C9-2 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 D2TCD Transducer Probe Open, Classified |
IYN | None listed |
| Aug 22, 2025 | Philips Ultrasound, Inc L18-5 Transducer Probe Open, Classified |
IYN | None listed |
| Aug 22, 2025 | Philips Ultrasound, Inc Mini Multi TEE Transducer Probe Open, Classified |
IYN | None listed |
| Aug 22, 2025 | Philips Ultrasound, Inc S12-4 Transducer Probe Open, Classified |
IYN | None listed |
| Aug 22, 2025 | Philips Ultrasound, Inc S4-2 Transducer Probe Open, Classified |
IYN | None listed |
| Aug 22, 2025 | Philips Ultrasound, Inc S7-3t Transducer Probe Open, Classified |
IYN | None listed |
| Aug 22, 2025 | Philips Ultrasound, Inc TRANSDUCER L12-5 Transducer Probe Open, Classified |
IYN | None listed |
| Aug 22, 2025 | Philips Ultrasound, Inc VL13-5 Transducer Probe Open, Classified |
IYN | None listed |
| Aug 22, 2025 | Philips Ultrasound, Inc X5-1 Transducer Probe Open, Classified |
IYN | None listed |
| Aug 22, 2025 | Philips Ultrasound, Inc X6-1 Transducer Probe Open, Classified |
IYN | None listed |
| Aug 22, 2025 | Philips Ultrasound, Inc X7-2 Transducer Probe Open, Classified |
IYN | None listed |
| Aug 22, 2025 | Philips Ultrasound, Inc X8-2t Transducer Probe Open, Classified |
IYN | None listed |
| Jul 2, 2025 | Philips Ultrasound, Inc Philips 3D9-3v Transducer. Open, Classified |
ITX | None listed |
| Jul 2, 2025 | Philips Ultrasound, Inc Philips L12-4 Transducer. Open, Classified |
ITX | None listed |
| Jul 2, 2025 | Philips Ultrasound, Inc Philips S7-3t Transducer. Open, Classified |
ITX | None listed |
| Jul 2, 2025 | Philips Ultrasound, Inc Philips VL13-5 Transducer. Open, Classified |
ITX | None listed |
| Jul 2, 2025 | Philips Ultrasound, Inc Philips X5-1 Transducer. Open, Classified |
ITX | None listed |
| Jul 2, 2025 | Philips Ultrasound, Inc Philips X6-1 Transducer. Open, Classified |
ITX | None listed |
| Jul 2, 2025 | Philips Ultrasound, Inc Philips X8-2t Transducer. Open, Classified |
ITX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.