The following data is part of a premarket notification filed by Mevisys Co. Ltd with the FDA for Voxelplus Pacs.
| Device ID | K022692 |
| 510k Number | K022692 |
| Device Name: | VOXELPLUS PACS |
| Classification | System, Image Processing, Radiological |
| Applicant | MEVISYS CO. LTD 1100 LAKEVIEW BLVD. Denton, TX 76208 |
| Contact | Carl Alletto |
| Correspondent | Carl Alletto MEVISYS CO. LTD 1100 LAKEVIEW BLVD. Denton, TX 76208 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-08-13 |
| Decision Date | 2002-10-11 |
| Summary: | summary |