510(k) K040050 ยท LLZ System, Image Processing, Radiological
INSTATRAK SYSTEM WITH MULTIPLE DATASET NAVIGATION, MODEL IT3500
| Applicant | Ge Medical Systems Navigation and Visualization IN, Salt Lake City UT, US |
| Decision | Substantially Equivalent, Mar 24, 2004 |
| Received | Jan 12, 2004 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K040050
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 12, 2012 | GE OEC Medical Systems, Inc InstaTrak with Multiple Dataset Navigation, 892.2050 System, Image Processing System, Model Number IT3500 Plus.
Product Usage: Usage:
The system is an aid to locate anatomical structures during op Terminated |
LLZ | None listed |
| Apr 11, 2011 | GE OEC Medical Systems, Inc Transmitter Sensor Cables, Part Numbers: 1002008, 1004587, 1007914-NAV, GE Healthcare Surgery, Salt Lake City, UT 84116.
Cables are used with InstraTrak Navigation Systems, Models IT3000, IT2500, IT25 Terminated |
LLZ | None listed |
| Apr 11, 2011 | GE OEC Medical Systems, Inc Receiver Sensor Cables, Part Numbers: 1001989, 1001990, 1004069, 1007907-NAV, GE Healthcare Surgery, Salt Lake City, UT 84116.
Cables are used with InstraTrak Navigation Systems, Models IT3000, IT2500 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 3500 Plus Navigation and Visualization System Terminated |
LLZ | None listed |
| Nov 3, 2004 | GE OEC Medical Systems,Inc Spine Clamp, an accessory to the InstaTrak 3500 Plus system. Clamp is attached to the spine to provide a mounting point for a transmitter. Terminated |
LLZ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.