510(k) K080555 ยท ITX Transducer, Ultrasonic, Diagnostic
SOFIA AUTOMATED TOMOGRAPHIC ULTRASOUND (ATUS)
| Applicant | Ivu Imaging Corporation, Grapevine TX, US |
| Decision | Substantially Equivalent, Jun 3, 2008 |
| Received | Feb 28, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K080555
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.