510(k) K913120 ยท IZI System, X-Ray, Angiographic
POLYSTAR ANGIOGRAPHIC X-RAY SYSTEM
| Applicant | Siemens Medical Solutions USA, Inc., Iselin NJ, US |
| Decision | Substantially Equivalent, Aug 16, 1991 |
| Received | Jul 15, 1991 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K913120
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 16, 2004 | Siemens Medical Solutions USA, Inc POLYSTAR, Angiographic X-Ray System, Model 1148902 Terminated |
IZI | None listed |
| Nov 16, 2004 | Siemens Medical Solutions USA, Inc POLYSTAR T.O.P., Angiographic X-Ray System, Model
Numbers 1148902 and 4784505. Terminated |
IZI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.