510(k) K960330 ยท LLZ System, Image Processing, Radiological
INSTATRAK
| Applicant | Visualization Technology, Inc., Woburn MA, US |
| Decision | Substantially Equivalent, Apr 8, 1996 |
| Received | Jan 24, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K960330
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 17, 2013 | GE OEC Medical Systems, Inc InstaTrak 3500 Plus, ENTrakTM Plus, InstaTrak 3500, ENTrakTM Computer-Assisted Navigation Systems (USA), Terminated |
LLZ | None listed |
| 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 |
| Jan 23, 2008 | GE OEC Medical Systems, Inc GE OEC, Insta Trak 3500 Plus with the Cranial Application for Image Guided Surgery, GE Healthcare, Surgery, Salt Lake City, UT 84116 Terminated |
LLZ | None listed |
| Aug 7, 2007 | GE OEC Medical Systems, Inc Cleaning probe included as an accessory to aspirators that are sterile packed single use disposable accessories to the GE InstaTrak 3500 Plus x-ray system. Probes are packaged and shipped together wit Terminated |
LLZ | None listed |
| May 11, 2005 | GE OEC Medical Systems,Inc ENTrak Navigation and Visualization System Terminated |
LLZ | None listed |
| May 11, 2005 | GE OEC Medical Systems,Inc ENTrak Plus Navigation and Visualization System Terminated |
LLZ | None listed |
| May 11, 2005 | GE OEC Medical Systems,Inc InstaTrak 3500 Navigation and Visualization System Terminated |
LLZ | None listed |
| Apr 8, 2005 | OEC Medical Systems, Inc ENTrak Navigation and Visualization System Terminated |
LLZ | None listed |
| Apr 8, 2005 | OEC Medical Systems, Inc ENTrak Plus 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.