510(k) K183109 ยท OWB Interventional Fluoroscopic X-Ray System
ControlRad Trace Model 8
| Applicant | Controlrad, Inc., Radnor PA, US |
| Decision | Substantially Equivalent, May 13, 2019 |
| Received | Nov 8, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K183109
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.