The following data is part of a premarket notification filed by Visualization Technology, Inc. with the FDA for Instatrak 3000 System With Fluorotrak Module, Model It3000.
| Device ID | K994270 |
| 510k Number | K994270 |
| Device Name: | INSTATRAK 3000 SYSTEM WITH FLUOROTRAK MODULE, MODEL IT3000 |
| Classification | System, Image Processing, Radiological |
| Applicant | VISUALIZATION TECHNOLOGY, INC. 200 RESEARCH DR. Wilmington, MA 01887 |
| Contact | Norma Lemay |
| Correspondent | Norma Lemay VISUALIZATION TECHNOLOGY, INC. 200 RESEARCH DR. Wilmington, MA 01887 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-12-20 |
| Decision Date | 2000-03-09 |
| Summary: | summary |