510(k) K053154 ยท IYN System, Imaging, Pulsed Doppler, Ultrasonic
MYLAB15/20 3D/4D ULTRASOUND IMAGING SYSTEM
| Applicant | Pie Medical, Indianpolis IN, US |
| Decision | Substantially Equivalent, Dec 16, 2005 |
| Received | Nov 14, 2005 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K053154
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.