510(k) K171755 ยท OWB Interventional Fluoroscopic X-Ray System
CS-series-FP with MX CFP 3131 or MX CFP 2222 Option Radiographic/Fluoroscopy System
| Applicant | Omega Medical Imaging, LLC, Sanford FL, US |
| Decision | Substantially Equivalent, Feb 9, 2018 |
| Received | Jun 13, 2017 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K171755
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.