510(k) K955519 ยท IZI System, X-Ray, Angiographic
ANALYTICAL REVIEW STATION
| Applicant | Camtronics, Ltd., Hartland WI, US |
| Decision | Substantially Equivalent, May 9, 1996 |
| Received | Dec 4, 1995 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K955519
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 30, 2005 | GE Medical Systems Information Technologies GE Healthcare Centricity Cardiology AI1000 Workstation version 4.2.6 and version 4.2.7.05 Terminated |
LLZ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.