The following data is part of a premarket notification filed by Visualization Technology, Inc. with the FDA for Instatrak.
| Device ID | K960330 |
| 510k Number | K960330 |
| Device Name: | INSTATRAK |
| Classification | System, Image Processing, Radiological |
| Applicant | VISUALIZATION TECHNOLOGY, INC. 30G SIXTH RD. Woburn, MA 01801 |
| Contact | Robert R Murfitt |
| Correspondent | Robert R Murfitt VISUALIZATION TECHNOLOGY, INC. 30G SIXTH RD. Woburn, MA 01801 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-01-24 |
| Decision Date | 1996-04-08 |
| Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() INSTATRAK 86455482 4862118 Live/Registered |
Kyzen Corporation 2014-11-15 |
![]() INSTATRAK 74665459 2039423 Live/Registered |
OEC MEDICAL SYSTEMS, INC. 1995-04-25 |
![]() INSTATRAK 74325955 not registered Dead/Abandoned |
METRO TRAFFIC CONTROL 1992-10-27 |