The following data is part of a premarket notification filed by Viatronix, Inc. with the FDA for Viatronic V3d Calcium Scoring.
| Device ID | K013146 |
| 510k Number | K013146 |
| Device Name: | VIATRONIC V3D CALCIUM SCORING |
| Classification | System, X-ray, Tomography, Computed |
| 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 | JAK |
| CFR Regulation Number | 892.1750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-09-20 |
| Decision Date | 2001-12-07 |
| Summary: | summary |