510(k) K102529 ยท OWB Interventional Fluoroscopic X-Ray System
D2RF DIGITAL DYNAMIC REMOTE SYSTEM
| Applicant | Stephanix Radiological Systems, Naples FL, US |
| Decision | Substantially Equivalent, Oct 7, 2010 |
| Received | Sep 2, 2010 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K102529
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 2, 2018 | Stephanix STEPHANIX D2RS Digital Dynamic Remote Systemhttp://cts.fda.gov/division-tracking/images/trash.png
Product The D2RS Digital Dynamic Remote System is indicated for use in generating fluoroscopic images Terminated |
OWB | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.