The following data is part of a premarket notification filed by Viatronix, Inc. with the FDA for Viatronix V3d Colon, Revision 1.3.
| Device ID | K040126 |
| 510k Number | K040126 |
| Device Name: | VIATRONIX V3D COLON, REVISION 1.3 |
| Classification | System, Image Processing, Radiological |
| Applicant | VIATRONIX, INC. 25 EAST LOOP RD., SUITE 204 Stony Brook, NY 11790 |
| Contact | Baman Pattanayak |
| Correspondent | Baman Pattanayak VIATRONIX, INC. 25 EAST LOOP RD., SUITE 204 Stony Brook, NY 11790 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-01-20 |
| Decision Date | 2004-04-19 |
| Summary: | summary |