510(k) K994270 ยท LLZ System, Image Processing, Radiological
INSTATRAK 3000 SYSTEM WITH FLUOROTRAK MODULE, MODEL IT3000
| Applicant | Visualization Technology, Inc., Wilmington MA, US |
| Decision | Substantially Equivalent, Mar 9, 2000 |
| Received | Dec 20, 1999 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K994270
| 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 |
| Aug 8, 2012 | GE OEC Medical Systems, Inc Radiological Image Processing System
The system is an aid to locate anatomical structures during open or percutaneous surgical procedures. It is indicated for use in medical conditions that may benef 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 |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.