510(k) K082543 ยท IYO System, Imaging, Pulsed Echo, Ultrasonic
SONOCINE ADJUNCTIVE BREAST ULTRASOUND SYSTEM (ABU), MODEL 100
| Applicant | Sonocine, Inc., Reno NV, US |
| Decision | Substantially Equivalent, Oct 14, 2008 |
| Received | Sep 3, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K082543
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.