The following data is part of a premarket notification filed by Viatronix, Inc. with the FDA for Viatronix V3d Colon.
| Device ID | K020658 |
| 510k Number | K020658 |
| Device Name: | VIATRONIX V3D COLON |
| Classification | System, Image Processing, Radiological |
| Applicant | VIATRONIX, INC. 25 EAST LOOP RD., SUITE 204 Stony Brook, NY 11790 |
| Contact | Baman Pattanayak |
| Correspondent | Jeff D Rongero UNDERWRITERS LABORATORIES, INC. 12 LABORATORY DR. Research Triangle, NC 27709 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2002-03-01 |
| Decision Date | 2002-03-07 |
| Summary: | summary |