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 |