The following data is part of a premarket notification filed by Vital Images, Inc. with the FDA for Advanced Diagnostic Viewer (aox), Model Vitred 1.3.
| Device ID | K990442 |
| 510k Number | K990442 |
| Device Name: | ADVANCED DIAGNOSTIC VIEWER (AOX), MODEL VITRED 1.3 |
| Classification | System, Image Processing, Radiological |
| Applicant | VITAL IMAGES, INC. 3100 WEST LAKE ST. Minneapolis, MN 55416 |
| Contact | Robert C Samec |
| Correspondent | Robert C Samec VITAL IMAGES, INC. 3100 WEST LAKE ST. Minneapolis, MN 55416 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-02-10 |
| Decision Date | 1999-05-11 |
| Summary: | summary |