The following data is part of a premarket notification filed by Virtual Radiologic Corporation with the FDA for Vrad Picture Archiving And Communications System Software.
| Device ID | K090649 |
| 510k Number | K090649 |
| Device Name: | VRAD PICTURE ARCHIVING AND COMMUNICATIONS SYSTEM SOFTWARE |
| Classification | System, Image Processing, Radiological |
| Applicant | VIRTUAL RADIOLOGIC CORPORATION 11995 SINGLETREE LANE Eden Prairie, MN 55344 |
| Contact | Kimberly Tokach |
| 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 | 2009-03-11 |
| Decision Date | 2009-03-27 |
| Summary: | summary |