510(k) K170133 ยท IYO System, Imaging, Pulsed Echo, Ultrasonic
FFR V2.5
| Applicant | Philips Volcano, San Diego CA, US |
| Decision | Substantially Equivalent, May 26, 2017 |
| Received | Jan 17, 2017 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K170133
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 12, 2019 | Volcano Corporation Philips Volcano FFR software used in the following systems connected to the McKesson, Schwarzer, and some Philips Xper Hemodynamic Systems (HMS): (1) Volcano Imaging System s5i, Part #807400001; (2) s Terminated |
IYO | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.