510(k) K172455 ยท IYO System, Imaging, Pulsed Echo, Ultrasonic
CORE M2 Vascular System, CORE M2 Software v4.2 Upgrade Kit, CORE M2 Software v4.2 Installation Kit
| Applicant | Volcano Corporation, San Diego CA, US |
| Decision | Substantially Equivalent, Oct 25, 2017 |
| Received | Aug 14, 2017 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K172455
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 17, 2018 | Volcano Corporation Philips Volcano CORE M2 Vascular System, Part # 400-0100.17, Rx Only.
Used for the qualitative and quantitative evaluation of vascular morphology in the coronary arteries and vessels of the periphera Terminated |
IYO | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.