510(k) K251650 · JAA System, X-Ray, Fluoroscopic, Image-Intensified
Insight Enhanced DRF (EN-1002-01)
| Applicant | Imaging Engineering, LLC, Gainesville FL, US |
| Decision | Substantially Equivalent, Sep 16, 2025 |
| Received | May 29, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K251650
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.