510(k) K992660 ยท OWB Interventional Fluoroscopic X-Ray System
URF DIGITAL - OT
| Applicant | Siemens Medical Solutions USA, Inc., Iselin NJ, US |
| Decision | Substantially Equivalent, Nov 5, 1999 |
| Received | Aug 9, 1999 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K992660
| 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 |
| Apr 11, 2013 | Siemens Medical Solutions USA, Inc Iconos R200 C20, Iconos R200 T20, Iconos R100, Iconos MD, Iconos RHD, Luminos RF Classic, Luminos Fusion or Luminos Select.
Angiographic x-ray system. Terminated |
JAA | None listed |
| Mar 27, 2010 | Siemens Medical Solutions USA, Inc Axiom Iconos R200 X-Ray Terminated |
JAA | None listed |
| Jun 16, 2009 | Siemens Medical Solutions USA, Inc Mavig Portegra 2 which is an accessory to the Siemens angiographic, fluoroscopic and radiographic imaging systems. Component material number 4787714 Upper Body radiation shield, Artis floor. Terminated |
IZI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.