510(k) K051602 ยท JAA System, X-Ray, Fluoroscopic, Image-Intensified
AXIOM SIRESKOP SD
| Applicant | Siemens Medical Systems, Inc., Mavern PA, US |
| Decision | Substantially Equivalent, Jul 7, 2005 |
| Received | Jun 16, 2005 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K051602
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 20, 2023 | Siemens Medical Solutions USA, Inc AXIOM Luminos TF, AXIOM Iconos R100, AXIOM Iconos R200 and AXIOM Luminos dRF Open, Classified |
OWB | None listed |
| Feb 23, 2011 | Siemens Medical Solutions USA, Inc AXIOM SIRESKOP SD, SIRESKOP SX, AXIOM LUMINOS
System, X-Ray, Fluoroscopic, image-intensified; solid state x-ray imager (flat panel/digital imager) Terminated |
MQB | None listed |
| Aug 13, 2010 | Siemens Medical Solutions USA, Inc SIEMENS AXIOM Luminos TF and Sireskop SD Solid State x-ray imager (flat panel/digital imager), Fluoroscopic x-ray diagnostic system. Terminated |
MQB | None listed |
| May 6, 2009 | Siemens Medical Solutions USA, Inc AXIOM Sireskop SD Model numbers 8890415 and 8890407. The product is intended for use as radiographic and fluoroscopic imaging device. Terminated |
MQB | None listed |
| Oct 10, 2008 | Siemens Medical Solutions USA, Inc AXIOM Luminos TF, model number 10093902
Intended to be used for procedures that involve high skin doses, which can result in deterministic effects. Terminated |
MQB | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.