# K072737: CSCS-001A Calcium Scoring Package

- Pathway: 510(k) (Traditional)
- Applicant: Toshiba America Medical Systems, In.C
- Decided: Oct 5, 2007 after 8 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 K945512 (1995). 9 ancestors in all.
45 later devices descend from it; 2 cite it directly.
0 of 55 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K020929: Smartscore 3.5; Smartscore 4.0; Smartscore 4.5, GE Medical Systems (2002) Summary page 1.
- K990426: Calcium Scoring, Siemens Medical Solutions USA, Inc. (1999). Our reading of the summary gave K990436, FDA’s number for Ultimax Trochanteric Intramedullary Rod System (Biodynamic Technologies, Inc.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Siemens Syngo Calcium Scoring”.
- K001682: Vscore with Ekg Signal Gating, Vital Images, Inc. (2000)

## Most influential descendants
- K083446: Cardiac Function Analysis, Calcium Scoring (2009), 29 descendants of its own
- K111373: CT42 Cardiac Computed Tomography (CT) Software (2011), 25 descendants of its own
- K203256: Imbio RV/LV Software (2021), 17 descendants of its own
- K172983: HealthCCS (2018), 14 descendants of its own
- K210085: HealthCCSng (2021), 9 descendants of its own

## Indications for use
The CSCS-001A is a non-invasive post processing package that can be used to evaluate calcified plaques in the coronary arteries, which may be a risk factor for coronary artery disease. This software can be used to generate both DiCOM reports and hard copy reports for the purpose of monitoring disease state over time.

Source page: https://510kreport.com/device/K072737
Methodology: https://510kreport.com/methodology