510(k) K231190 ยท IYN System, Imaging, Pulsed Doppler, Ultrasonic
EPIQ Series Diagnostic Ultrasound System
| Applicant | Philips Ultrasound, LLC, Bothell WA, US |
| Decision | Substantially Equivalent, May 12, 2023 |
| Received | Apr 26, 2023 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K231190
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 31, 2025 | Philips Ultrasound, LLC Philips EPIQ Ultrasound Systems (various models) used in conjunction with the X5-1c transducer
REF: , , 795200, 795201, 795231, 795232, 795234
REF: 795117, 795122 Completed |
IYN | None listed |
| Aug 22, 2025 | Philips Ultrasound, Inc mL26-8 Transducer Probe Open, Classified |
IYN | None listed |
| Nov 9, 2023 | Philips Ultrasound, Inc. Philips EPIQ Diagnostic Ultrasound System Models: EPIQ 7G(model # 795200), EPIQ 7C (Model # 795201), EPIQ 7W (Model # 795202), EPIQ 5G (model # 795204), EPIQ 5W (model # 795206), EPIQ CVx (Model # 79 Completed |
IYN | None listed |
| Nov 9, 2023 | Philips Ultrasound, Inc. Philips Affiniti 70, Diagnostic Ultrasound System Model # 795210 Completed |
IYN | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.