510(k) K072517 ยท IYO System, Imaging, Pulsed Echo, Ultrasonic
ILAB ULTRASOUND IMAGING SYSTEM, VERSION 1.3
| Applicant | Boston Scientific Corp, Fremont CA, US |
| Decision | Substantially Equivalent, Sep 26, 2007 |
| Received | Sep 7, 2007 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K072517
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 23, 2008 | Boston Scientific Corporation iLab Ultrasound Imaging System, Models 120INS and 240INS, manufactured by Boston Scientific Corporation, Fremont, CA 94538 Terminated |
IYO | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.