510(k) K200396 ยท JAA System, X-Ray, Fluoroscopic, Image-Intensified
Insight Enhanced DRF Digital Imaging System
| Applicant | Imaging Engineering, LLC, Cape Coral FL, US |
| Decision | Substantially Equivalent, Mar 6, 2020 |
| Received | Feb 18, 2020 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K200396
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.