# K242781: cvi42 Software Application

- Pathway: 510(k) (Special)
- Applicant: Circle Cardiovascular Imaging, Inc.
- Decided: Oct 15, 2024 after 29 days
- Product code: QIH (Automated Radiological Image Processing Software)
- 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: 14 generations back to K935595 (1995). 121 ancestors in all.
No later device cites it as a predicate yet.
0 of 122 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K082628: CMR42 Cardiac Mri Imaging System, 2.1.23, Circle Cardiovascular Imaging, Inc. (2008) Summary page 6.
- K111373: CT42 Cardiac Computed Tomography (CT) Software, Circle Cardiovascular Imaging, Inc. (2011) Summary page 6.
- K141480: CVI42, Circle Cardiovascular Imaging, Inc. (2014) Summary page 6.
- K213998: cvi42 Auto Imaging Software Application, Circle Cardiovascular Imaging, Inc. (2022) Summary page 6.
- K232661: Myocardial Strain Software Application, Circle Cardiovascular Imaging (2023) Summary page 11.
- K241038: Cardiac CT Function Software Application, Circle Cardiovascular Imaging (2024) Summary page 11.

## Indications for use
cvi42 is intended to be used for viewing, post-processing, qualitative and quantitative evaluation of cardiovascular magnetic resonance (MR) images and computed tomography (CT) images in a Digital Imaging and Communications in Medicine (DICOM) Standard format. It enables: * Importing cardiac MR & CT Images in DICOM format. » Supporting clinical diagnostics by qualitative analysis of cardiac MR & CT images using display functionality such as panning, windowing, zooming, navigation through series/slices and phases, 3D reconstruction of images including multiplanar reconstructions of the images. » Supporting clinical diagnostics by quantitative measurement of the heart and adjacent vessels in cardiac MR & CT images, specifically signal intensity, distance, area, volume, and mass. » Supporting clinical diagnostics by using area and volume for measuring cardiac function and derived parameters cardiac output and cardiac index in long axis and short axis cardiac MR & CT images. » Flow quantifications based on velocity encoded cardiac MR images (including two and four dimensional flow analysis). « Strain analysis of cardiac MR images by providing measurements of 2D LV myocardial function (displacement, velocity, strain, strain rate, time to peak, and torsion). » Supporting clinical diagnostics of cardiac CT images including quantitative measurements of calcified plaques in the coronary arteries (calcium scoring), specifically Agatston and volume and mass calcium scores, visualization and quantitative measurement of heart structures including coronaries, femoral, aortic, and mitral valves. » Evaluating CT and MR images of blood vessels. Combining digital image processing and visualization tools such as multiplanar reconstruction (MPR), thin/thick maximum intensity projection (MIP), inverted MIP thin/thick, volume rendering technique (VRT), curved planar reformation (CPR), processing tools such as bone removal (based on both single energy and dual energy) table removal and evaluation tools (vessel centerline calculation, lumen calculation, stenosis calculation) and reporting tools (lesion location, lesion characteristics) and key images. The software package is designed to support the physician in confirming the presence or absence of physician identified lesion in blood vessels and evaluation, documentation and follow up of any such lesions. cvi42 shall be used by qualified medical professionals, experienced in examining and evaluating cardiovascular MR or CT images, for the purpose of obtaining diagnostic information as part of a comprehensive diagnostic decision-making process. cvi42 is a software application that can be used as a stand-alone product or in a networked environment. The target population for cvi42 and its manual workflows is not restricted; however, cvi42’'s semi-automated machine learning algorithms, included in the MR Function and CORE CT modules, are intended for an adult population. Further, image acquisition by a cardiac MR or CT scanner may limit the use of the software for certain sectors of the general public. cvi42 shall not be used to view or analyze images of any part of the body except the cardiac images acquired from a cardiovascular magnetic resonance or computed tomography scanner.

Source page: https://510kreport.com/device/K242781
Methodology: https://510kreport.com/methodology