# K990426: Calcium Scoring

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Medical Solutions USA, Inc.
- Decided: May 12, 1999 after 90 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: 2 generations back to K945428 (1995). 3 ancestors in all.
166 later devices descend from it; 5 cite it directly.
0 of 170 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 2.
- K960911: Netra Workstation System & Netra MD Software, Scimage, Inc. (1996) Summary page 2.

## Most influential descendants
- K043111: Plaqueview Software, Model CSPV-0001A (2004), 112 descendants of its own
- K061624: Vitrea, Version 3.9 (2006), 111 descendants of its own
- K071331: Vitrea Version 4.0 (2007), 82 descendants of its own
- K072737: CSCS-001A Calcium Scoring Package (2007), 45 descendants of its own
- K083446: Cardiac Function Analysis, Calcium Scoring (2009), 29 descendants of its own

## Indications for use
From user specified sets of CT cardiac images, Calcium Scoring can be used to: - Allow the user to interactively indicate regions of detected calcification To allow the user to allocate each detected region to one of several coronary arteries To estimate algorithmically a score for the amount of detected calcification in each allocated artery To prepare reports including caicium score data, imagery, ECG traces, Comparison of score to cited literature and additional relevant information The calcium-scoring package is a diagnostic tool that can be used to evaluate the caicified plaques in the caronary arteries, which is a risk factor for coronary artery disease. Calcium scoring may be used to monitor the progression or regression overtime of the amount or volume of calcium in the coranary arteries, which may be related to the pregnosis of a cardiac attack.

Source page: https://510kreport.com/device/K990426
Methodology: https://510kreport.com/methodology