The following data is part of a premarket notification filed by Vital Images, Inc. with the FDA for Vitrea2 Version 3.5.
| Device ID | K040305 |
| 510k Number | K040305 |
| Device Name: | VITREA2 VERSION 3.5 |
| Classification | System, Image Processing, Radiological |
| Applicant | VITAL IMAGES, INC. 3300 FERNBROOK LN. NORTH SUITE 200 Plymouth, MN 55447 |
| Contact | Timothy J Kappers |
| Correspondent | Mark Job REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2004-02-09 |
| Decision Date | 2004-02-24 |
| Summary: | summary |