510(k) K050718 ยท MQB Solid State X-Ray Imager (Flat Panel/Digital Imager)
DDRCOMBI TRAUMA
| Applicant | Swissray International, Inc., Elizabeth NJ, US |
| Decision | Substantially Equivalent, May 26, 2005 |
| Received | Mar 21, 2005 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K050718
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 8, 2019 | Swissray Medical AG ddRCombi Plus FP, Model Number 8.2000.0070.0 (US Version), 8.2000.0060.0 (Europe Version)
The ddRCombi Plus FP is a fully digital, multifunctional X-ray system that allows the direct digitization of Terminated |
MQB | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.