The following data is part of a premarket notification filed by Viztek, Inc. with the FDA for Onyx-rad Telemedicine Pacs.
| Device ID | K003607 |
| 510k Number | K003607 |
| Device Name: | ONYX-RAD TELEMEDICINE PACS |
| Classification | System, Image Processing, Radiological |
| Applicant | VIZTEK, INC. 6491 POWERS AVE. Jacksonville, FL 32217 |
| Contact | Josip Cermin |
| Correspondent | Josip Cermin VIZTEK, INC. 6491 POWERS AVE. Jacksonville, FL 32217 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-11-22 |
| Decision Date | 2001-02-15 |