510(k) K152554 ยท IYO System, Imaging, Pulsed Echo, Ultrasonic
Site-Rite 8 Ultrasound System, Site-Rite 8 Ultrasound System with Pinpoint GT Technology
| Applicant | C.R. Bard, Inc., Salt Lake Ciy, UT, US |
| Decision | Substantially Equivalent, Dec 14, 2015 |
| Received | Sep 8, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K152554
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 4, 2019 | Becton Dickinson & Company Site~Rite 8 Ultrasound Systems-intended for diagnostic ultrasound imaging of the human body.
Site~Rite 8 Ultrasound System, Catalog No.9770500
Refurbished, Site~Rite 8 System, Catalog No.9770500R
Site Terminated |
IYO | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.