510(k) K061054 ยท MQB Solid State X-Ray Imager (Flat Panel/Digital Imager)
AXIOM ARISTOS FX PLUS
| Applicant | Siemens Medical Solutions USA, Inc., Malvern PA, US |
| Decision | Substantially Equivalent, May 9, 2006 |
| Received | Apr 17, 2006 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K061054
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 6, 2020 | Siemens Medical Solutions USA, Inc System AXIOM Aristos FX Plus - A dedicated x-ray system with a flat panel detector which allows the acquisition of x-ray exposures without the use of conventional film/screen systems; and allows radio Terminated |
MQB | None listed |
| Jan 25, 2012 | Siemens Medical Solutions USA, Inc Siemens AXIOM Aristos FX Plus solid state x-ray imager.
Image-intensified fluoroscopic x-ray system. Terminated |
MQB | None listed |
| Apr 12, 2011 | Siemens Medical Solutions USA, Inc Axiom Aristos FX and FX Plus System
Intended use: Stationary x-ray system Terminated |
KPR | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.