510(k) K951358 ยท JAA System, X-Ray, Fluoroscopic, Image-Intensified
SIRESKOP SX
| Applicant | Siemens Medical Solutions USA, Inc., Iselin NJ, US |
| Decision | Substantially Equivalent, May 15, 1995 |
| Received | Mar 24, 1995 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K951358
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| 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 |
| May 6, 2009 | Siemens Medical Solutions USA, Inc AXIOM Sireskop SX Model numbers 3111676 and 3111668. The product is intended for use as radiographic and fluoroscopic imaging device. Terminated |
JAA | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.