The following data is part of a premarket notification filed by Voyager Imaging with the FDA for Voyager Pacs System.
| Device ID | K062062 |
| 510k Number | K062062 |
| Device Name: | VOYAGER PACS SYSTEM |
| Classification | System, Image Processing, Radiological |
| Applicant | VOYAGER IMAGING 1600 MANCHESTER WAY Corinth, TX 76210 |
| Contact | Carl Alletto |
| Correspondent | Carl Alletto VOYAGER IMAGING 1600 MANCHESTER WAY Corinth, TX 76210 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-07-20 |
| Decision Date | 2006-09-11 |
| Summary: | summary |