510(k) K983529 ยท LLZ System, Image Processing, Radiological
INSTATRAK 3000
| Applicant | Visualization Technology, Inc., North Attleboro MA, US |
| Decision | Substantially Equivalent, Dec 31, 1998 |
| Received | Oct 8, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K983529
| 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 |
| Mar 30, 2007 | GE OEC Medical Systems,Inc InstaTrak 3500 Plus system with cranial application (aid to the surgeon for locating anatomical structures in the human body) Terminated |
LLZ | None listed |
| Apr 7, 2006 | GE OEC Medical Systems,Inc GE Healthcare Navigation Pin Transmitter (GE P/N 1004070) -Medical Systems InstaTrak Pin Transmitter Terminated |
LLZ | None listed |
| May 11, 2005 | GE OEC Medical Systems,Inc InstaTrak 3500 Navigation and Visualization System Terminated |
LLZ | None listed |
| May 11, 2005 | GE OEC Medical Systems,Inc InstaTrak 3500 Plus Navigation and Visualization System Terminated |
LLZ | None listed |
| Apr 8, 2005 | OEC Medical Systems, Inc InstaTrak 3000 Navigation and Visualization System Terminated |
LLZ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.