510(k) K191025 ยท IZL System, X-Ray, Mobile
DRX-Revolution Mobile X-ray System
| Applicant | Carestream Health, Inc., Rochester NY, US |
| Decision | Substantially Equivalent, May 17, 2019 |
| Received | Apr 18, 2019 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K191025
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 1, 2023 | Carestream Health, Inc. DRX Revolution Mobile X-Ray System Open, Classified |
IZL | None listed |
| Nov 9, 2023 | Carestream Health, Inc. The DRX-Revolution Mobile X-Ray System is a diagnostic mobile x-ray system utilizing digital radiography (DR) technology. the system consists of a self-contained x-ray generator, image receptor(s), im Open, Classified |
IZL | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.