The following data is part of a premarket notification filed by Universal Pacs, Inc. with the FDA for Unipacs Workstation.
| Device ID | K023476 |
| 510k Number | K023476 |
| Device Name: | UNIPACS WORKSTATION |
| Classification | System, Image Processing, Radiological |
| Applicant | UNIVERSAL PACS, INC. 127 ALBERT HART DR. Baton Rouge, LA 70803 |
| Contact | John M Tyler |
| Correspondent | John M Tyler UNIVERSAL PACS, INC. 127 ALBERT HART DR. Baton Rouge, LA 70803 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-10-16 |
| Decision Date | 2003-01-07 |
| Summary: | summary |