The following data is part of a premarket notification filed by Vital Images, Inc. with the FDA for Vitrea 2 Ct Perfusion Option.
| Device ID | K003639 |
| 510k Number | K003639 |
| Device Name: | VITREA 2 CT PERFUSION OPTION |
| Classification | System, X-ray, Tomography, Computed |
| Applicant | VITAL IMAGES, INC. 3300 FERNBROOK LN. NORTH SUITE 200 Plymouth, MN 55447 |
| Contact | Robert C Samec |
| Correspondent | Robert C Samec VITAL IMAGES, INC. 3300 FERNBROOK LN. NORTH SUITE 200 Plymouth, MN 55447 |
| Product Code | JAK |
| CFR Regulation Number | 892.1750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-11-24 |
| Decision Date | 2001-01-23 |