510(k) K182834 ยท JAA System, X-Ray, Fluoroscopic, Image-Intensified
CS-series-FP with Optional ROI Accessory CA-100S
| Applicant | Omega Medical Imaging, LLC, Sanford FL, US |
| Decision | Substantially Equivalent, Mar 29, 2019 |
| Received | Oct 9, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K182834
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.