The following data is part of a premarket notification filed by Viatronix, Inc. with the FDA for Viatronix Visualization System (vvs).
| Device ID | K002780 |
| 510k Number | K002780 |
| Device Name: | VIATRONIX VISUALIZATION SYSTEM (VVS) |
| Classification | System, Image Processing, Radiological |
| Applicant | VIATRONIX, INC. 55 Northern Blvd. Suite 200 Great Neck, NY 11021 |
| Contact | Susan D Goldstein-falk |
| Correspondent | Susan D Goldstein-falk VIATRONIX, INC. 55 Northern Blvd. Suite 200 Great Neck, NY 11021 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-09-06 |
| Decision Date | 2000-11-17 |