510(k) K202394 ยท KPR System, X-Ray, Stationary
EOSedge
| Applicant | Eos Imaging, Paris, FR |
| Decision | Substantially Equivalent, Sep 16, 2020 |
| Received | Aug 21, 2020 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K202394
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 22, 2020 | EOS Imaging The EOSedge system may acquire two simultaneous orthogonal planar images for a standing or seated patient at low dose. The scan length is defined by the user and may cover the whole body or a specific Terminated |
KPR | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.