The following data is part of a premarket notification filed by Virtual Radiologic Corporation with the FDA for Vrad Pacs With Mammography.
| Device ID | K162145 |
| 510k Number | K162145 |
| Device Name: | VRad PACS With Mammography |
| Classification | System, Image Processing, Radiological |
| Applicant | Virtual Radiologic Corporation 11995 Singletree Lane, Suite 500 Eden Prairie, MN 55344 |
| Contact | Melinda Sewell |
| Correspondent | Melinda Sewell Virtual Radiologic Corporation 11995 Singletree Lane, Suite 500 Eden Prairie, MN 55344 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-08-01 |
| Decision Date | 2016-10-25 |
| Summary: | summary |