510(k) K192936 ยท IZL System, X-Ray, Mobile
Soltus 500
| Applicant | Sedecal., Sa., Algete, ES |
| Decision | Substantially Equivalent, Nov 15, 2019 |
| Received | Oct 18, 2019 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K192936
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 4, 2022 | SEDECAL SA Sedecal Soltus
Battery Mobile X-Ray System REF Soltus 450
Battery Mobile X-Ray System REF Soltus 500 Open, Classified |
IZL | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.