# K111373: CT42 Cardiac Computed Tomography (CT) Software

- Pathway: 510(k) (Traditional)
- Applicant: Circle Cardiovascular Imaging, Inc.
- Decided: Aug 23, 2011 after 99 days
- Product code: LLZ (System, Image Processing, Radiological)
- Device class: 2
- Regulation: 21 CFR 892.2050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K945512 (1995). 15 ancestors in all.
25 later devices descend from it; 3 cite it directly.
0 of 41 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K083446: Cardiac Function Analysis, Calcium Scoring, Ziosoft, Inc. (2009) Summary page 4.

## Most influential descendants
- K203256: Imbio RV/LV Software (2021), 17 descendants of its own
- K213998: cvi42 Auto Imaging Software Application (2022), 7 descendants of its own
- K221100: Viz RV/LV (2022), 4 descendants of its own
- K230534: BriefCase-Quantification (2023), 3 descendants of its own
- K212624: EFAI Intelligent Cardiothoracic Ratio (iCTR) Assessment System (2022), 3 descendants of its own

## Indications for use
ct42 is intended to be used for viewing, post-processing and quantitative evaluation of cardiovascular computed tomography (CT) images in a Digital Imaging and Communications in Medicine (DICOM) Standard format. It enables; * Importing Cardiac CT Images in DICOM format * Supporting clinical diagnostics by qualitative analysis of the cardiac CT images using display functionality such as panning, windowing, zooming, navigation through series/slices and phases, 3D reconstruction of images including multi-planner reconstructions of the images. * Supporting clinical diagnostics by quantitative measurement of the heart and adjacent vessels in cardiac CT images, specifically distance, area, volume and mass * Supporting clinical diagnostics by using area and volume measurements for measuring LV function and derived parameters cardiac output and cardiac index in long axis and short axis cardiac CT images. * Supporting clinical diagnostics by quantitative measurements of calcified plaques in the coronary arteries (calcium scoring), specifically Agatston and volume and mass calcium scores It shall be used by qualified medical professionals, experienced in examining and evaluating cardiovascular CT images, for the purpose of obtaining diagnostic information as part of a comprehensive diagnostic decision-making process. ct42 is a software application that can be used as a stand-alone product or in a networked environment. The target population for the ct42 is not restricted, however the image acquisition by a cardiac CT scanner may limit the use of the device for certain sectors of the general public. ct42 shall not be used to view or analyze images of any part of the body except the cardiac CT images acquired from a cardiovascular CT scanner.

Source page: https://510kreport.com/device/K111373
Methodology: https://510kreport.com/methodology