The following data is part of a premarket notification filed by Mercury Computer Systems, Inc with the FDA for Visage Pacs/cs, Release Version 5.0.
| Device ID | K072205 |
| 510k Number | K072205 |
| Device Name: | VISAGE PACS/CS, RELEASE VERSION 5.0 |
| Classification | System, Image Processing, Radiological |
| Applicant | MERCURY COMPUTER SYSTEMS, INC BEIM STROHHAUSE 27 Hamburg, DE 20097 |
| Contact | Martin Gabler |
| Correspondent | Martin Gabler MERCURY COMPUTER SYSTEMS, INC BEIM STROHHAUSE 27 Hamburg, DE 20097 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-08-08 |
| Decision Date | 2007-08-29 |
| Summary: | summary |