510(k) K191310 ยท JAA System, X-Ray, Fluoroscopic, Image-Intensified
Insight Essentials DRF Digital Imaging System
| Applicant | Imaging Engineering, LLC, Cape Coral FL, US |
| Decision | Substantially Equivalent, Jun 10, 2019 |
| Received | May 15, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K191310
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.