510(k) K191813 ยท IZL System, X-Ray, Mobile
MobileDiagnost wDR 2.2
| Applicant | Sedecal., Sa., Algete, ES |
| Decision | Substantially Equivalent, Aug 2, 2019 |
| Received | Jul 5, 2019 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K191813
| 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 |
| Oct 23, 2025 | SEDECAL SA Model Number SM-40HF-B-D-C; 40KW CANON READY.005, 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 |
| Jun 30, 2023 | SEDECAL SA wDR 2.2 Mobile Digital 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.