510(k) K141895 ยท IZL System, X-Ray, Mobile
MOBILEDIAGNOST WDR
| Applicant | Sedecal., Sa., Seneca SC, US |
| Decision | Substantially Equivalent, Sep 18, 2014 |
| Received | Jul 14, 2014 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K141895
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 23, 2025 | SEDECAL SA MobileDiagnost wDR 2.2; Model Number REF 9890-010-89522, Mobile X-ray system Open, Classified |
IZL | None listed |
| Feb 14, 2024 | SEDECAL SA MobileDiagnost wDR, Model numbers 712001, 712002, 712004, 712006, and 712007 Open, Classified |
IZL | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.