510(k) K221803 ยท IZL System, X-Ray, Mobile
PHOENIX/AeroDR TX m01 and PHOENIX/mKDR Xpress.
| Applicant | Sedecal., Sa., Algete, ES |
| Decision | Substantially Equivalent, Jul 18, 2022 |
| Received | Jun 22, 2022 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K221803
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 2, 2023 | SEDECAL SA Phoenix mKDR Xpress, digital mobile diagnostic x-ray system Open, Classified |
IZL | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.