510(k) K003510 ยท LLZ System, Image Processing, Radiological
INSTATRAK SYSTEM WITH FLUOROCAT, MODEL IT3500
| Applicant | Visualization Technology, Inc., Wilmington MA, US |
| Decision | Substantially Equivalent, Feb 12, 2001 |
| Received | Nov 14, 2000 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K003510
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 22, 2012 | GE OEC Medical Systems, Inc OEC InstaTrak 3500, picture archiving and communications system intended as an aid to locate anatomical structures during open percutaneous surgical procedures. It is indicated for use in medical con Terminated |
LLZ | None listed |
| Apr 8, 2005 | OEC Medical Systems, Inc InstaTrak 3500 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.