510(k) K112997 ยท IYN System, Imaging, Pulsed Doppler, Ultrasonic
HD-IVUS ULTRASOUND IMAGING SYSTEM
| Applicant | Silicon Vally Medical Instruments, Inc., Fremont CA, US |
| Decision | Substantially Equivalent, Dec 17, 2011 |
| Received | Oct 7, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K112997
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.