510(k) K982994 ยท LLZ System, Image Processing, Radiological
SKULL BASE INSTATRAK SYSTEM
| Applicant | Visualization Technology, Inc., North Attleboro MA, US |
| Decision | Substantially Equivalent, Nov 16, 1998 |
| Received | Aug 27, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K982994
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 28, 2012 | GE OEC Medical Systems, Inc OEC IT3000; IT2500 (EnTrak); IT2500 Plus (EnTrak Plus); IT3500 (InstaTrak); IT3500 Plus (InstaTrak Plus); ConneCTstat; and ConneCTstat Plus picture archiving and communications systems. The systems a Terminated |
LLZ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.