The following data is part of a premarket notification filed by Visage Imaging, Inc. with the FDA for Visage Pacs, Version 6.0/cs 3.1.
| Device ID | K082269 |
| 510k Number | K082269 |
| Device Name: | VISAGE PACS, VERSION 6.0/CS 3.1 |
| Classification | System, Image Processing, Radiological |
| Applicant | VISAGE IMAGING, INC. LEPSIUSSTRASSE 70 Berlin, DE 12163 |
| Contact | Stefan Strowich |
| Correspondent | Stefan Strowich VISAGE IMAGING, INC. LEPSIUSSTRASSE 70 Berlin, DE 12163 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-08-11 |
| Decision Date | 2008-12-12 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04251332910031 | K082269 | 000 |
| 04251332910024 | K082269 | 000 |
| 04251332910017 | K082269 | 000 |
| 04251332910000 | K082269 | 000 |
| 04251332910048 | K082269 | 000 |
| 04251332910062 | K082269 | 000 |
| 04251332910079 | K082269 | 000 |
| 04251332910086 | K082269 | 000 |
| 04251332910055 | K082269 | 000 |