The following data is part of a premarket notification filed by Ge Medical Systems Navigation And Visualization In with the FDA for Instatrak System With Multiple Dataset Navigation, Model It3500.
| Device ID | K040050 |
| 510k Number | K040050 |
| Device Name: | INSTATRAK SYSTEM WITH MULTIPLE DATASET NAVIGATION, MODEL IT3500 |
| Classification | System, Image Processing, Radiological |
| Applicant | GE MEDICAL SYSTEMS NAVIGATION AND VISUALIZATION IN 384 WRIGHT BROTHERS DRIVE Salt Lake City, UT 84116 |
| Contact | Jeff Wagner |
| Correspondent | Jeff Wagner GE MEDICAL SYSTEMS NAVIGATION AND VISUALIZATION IN 384 WRIGHT BROTHERS DRIVE Salt Lake City, UT 84116 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-01-12 |
| Decision Date | 2004-03-24 |
| Summary: | summary |