510(k) K221081 ยท IZL System, X-Ray, Mobile
iQFlex M Mobile X-ray System, iQFlex MD Mobile X-ray System
| Applicant | First Source, Inc., Rochester NY, US |
| Decision | Substantially Equivalent, Jun 13, 2022 |
| Received | Apr 12, 2022 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K221081
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 1, 2024 | First Source Inc First Source iQ Flex M. Portable cart and platform that supports an X-ray system and laptop computer. Open, Classified |
IZL | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.