510(k) K152316 ยท IYO System, Imaging, Pulsed Echo, Ultrasonic
iLab Ultrasound Imaging System
| Applicant | Boston Scientific, Fremont CA, US |
| Decision | Substantially Equivalent, Sep 18, 2015 |
| Received | Aug 17, 2015 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K152316
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.