The following data is part of a premarket notification filed by Viatronix, Inc. with the FDA for Viatronix V3d-cardiac, Revision 1.0.
| Device ID | K083293 |
| 510k Number | K083293 |
| Device Name: | VIATRONIX V3D-CARDIAC, REVISION 1.0 |
| Classification | System, X-ray, Tomography, Computed |
| Applicant | VIATRONIX, INC. 25 HEALTH SCIENCES DR. SUITE 203/204 Stony Brook, NY 11790 |
| Contact | Dongqing Chen |
| Correspondent | Jeff D Rongero UNDERWRITERS LABORATORIES, INC. 12 LABORATORY DR. Research Triangle, NC 27709 |
| Product Code | JAK |
| CFR Regulation Number | 892.1750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2008-11-10 |
| Decision Date | 2008-12-05 |
| Summary: | summary |