510(k) K130173 ยท IYN System, Imaging, Pulsed Doppler, Ultrasonic
SONOSITE MAXX SERIES ULTRASOUND SYSTEM
| Applicant | FUJIFILM Sonosite, Inc., Bothell WA, US |
| Decision | Substantially Equivalent, Mar 25, 2013 |
| Received | Jan 24, 2013 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K130173
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 18, 2013 | SonoSite, Inc. P21x/5-1 MHz transducer, Part Number P07698-23
Product Usage: The P21x/5-1 MHz phased array transducer is designed for cardiac, abdominal and obstetric, TCD and orbital exams. It supports 2D with So Terminated |
IYO | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.