510(k) K210469 ยท JAA System, X-Ray, Fluoroscopic, Image-Intensified
Insight Agile DRF
| Applicant | Imaging Engineering, LLC, Cape Coral FL, US |
| Decision | Substantially Equivalent, Jul 27, 2021 |
| Received | Feb 16, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K210469
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.