# K040782: N-Vivo Calcium Score on IA Chassis Release, Model Release X.XX

- Pathway: 510(k) (Traditional)
- Applicant: Image Analysis, Inc.
- Decided: Jul 13, 2004 after 109 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: 4 generations back to K945188 (1995). 11 ancestors in all.
No later device cites it as a predicate yet.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K972903: Imatron Ultra Access Workstation with Cardiac Software Extensions, Imatron, Inc. (1997) Summary page 1.
- K990241: Accuimage, Accuview Diagnostic Imaging, Workstation W/Accuscore, Accuanalyze, Accuscope, Accushade, Accuvrt, and Accumip, Accuimage Diagnostics Corp. (1999) Summary page 1.
- K891931: QCT-Lung Nodule (TM) Analysis Package, Image Analysis, Inc. (1989) Summary page 1.

## Indications for use
N-VivoTM Calcium Score is a calibrated software program for non-invasive identification and quantification of calcified plaques in the coronary arteries and aorta using CT images. The software runs on a standard PC with basic image processing, database and reporting functions. N-VivoTM may be used to monitor progression/regression of calcium which may be useful in the prognosis of cardiovascular disease.

Source page: https://510kreport.com/device/K040782
Methodology: https://510kreport.com/methodology