# K013146: Viatronic V3D Calcium Scoring

- Pathway: 510(k) (Traditional)
- Applicant: Viatronix, Inc.
- Decided: Dec 7, 2001 after 78 days
- Product code: JAK (System, X-Ray, Tomography, Computed)
- Device class: 2
- Regulation: 21 CFR 892.1750
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K945512 (1995). 5 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K003484: Netra Workstation and Netramd Software, Scimage, Inc. (2001) Summary page 1.
- K982004: CT Coronary Artery Calcification Scoring (Cacs) Option for Advantage Windows, General Electric Co. (1998) Summary page 1.
- K001682: Vscore with Ekg Signal Gating, Vital Images, Inc. (2000) Summary page 1.

## Most influential descendants
- K032823: Medicheart, Model Release 1 (2003), 0 descendants of its own

## Indications for use
The Viatronix V3D Calcium Scoring System is intended to be used by a trained physician for the review and analysis of CT images as an aid in cardiac analysis.

Source page: https://510kreport.com/device/K013146
Methodology: https://510kreport.com/methodology