510(k) K191713 · JAA System, X-Ray, Fluoroscopic, Image-Intensified
CS-series-FP Radiographic / Fluoroscopic Systems with Optional CA-100S / FluoroShield (ROI Assembly)
| Applicant | Omega Medical Imaging, LLC, Sanford FL, US |
| Decision | Substantially Equivalent, Oct 4, 2019 |
| Received | Jun 26, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K191713
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.