The following data is part of a premarket notification filed by Mercury Computer Systems, Inc with the FDA for Visage Pacs/cs, Release Version 4.1.
| Device ID | K062490 |
| 510k Number | K062490 |
| Device Name: | VISAGE PACS/CS, RELEASE VERSION 4.1 |
| Classification | System, Image Processing, Radiological |
| Applicant | MERCURY COMPUTER SYSTEMS, INC 199 RIVERNECK ROAD, Chelmsford, MA 01824 |
| Contact | Richard Glasheen |
| Correspondent | Richard Glasheen MERCURY COMPUTER SYSTEMS, INC 199 RIVERNECK ROAD, Chelmsford, MA 01824 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-08-25 |
| Decision Date | 2006-10-27 |
| Summary: | summary |