# K213998: cvi42 Auto Imaging Software Application

- Pathway: 510(k) (Traditional)
- Applicant: Circle Cardiovascular Imaging, Inc.
- Decided: Jul 28, 2022 after 219 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: 7 generations back to K945512 (1995). 23 ancestors in all.
7 later devices descend from it; 6 cite it directly.
0 of 31 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 4.
- K141480: CVI42, Circle Cardiovascular Imaging, Inc. (2014) Summary page 4.
- K111373: CT42 Cardiac Computed Tomography (CT) Software, Circle Cardiovascular Imaging, Inc. (2011) Summary page 4.

## Most influential descendants
- K243038: Salix Central (2025), 1 descendant of its own
- K251027: cvi42 Coronary Plaque Software Application (2025), 0 descendants of its own
- K251837: Salix Coronary Plaque (V1.0.0) (2025), 0 descendants of its own
- K241922: Myomics (2025), 0 descendants of its own
- K242062: 1CMR Pro (2024), 0 descendants of its own

## Indications for use
cvi42 Auto is intended to be used for viewing, post-processing, qualitative and quantitative evaluation of cardiovascular magnetic resonance (MR) and computed tomography (CT) images in a Digital Imaging and Communications in Medicine (DICOM) Standard format. It enables a set of tools to assist physicians in qualitative assessment of cardiac images and quantitative measurements of the heart and adjacent vessels; perform calcium scoring; and to confirm the presence or absence of physician-identified lesion in blood vessels. The target population for cvi42 Auto's manual workflows is not restricted; however, cvi42 Auto's semi-automated machine learning algorithms are intended for an adult population. cvi42 Auto shall be used only for cardiac images acquired from an MR or CT scanner. It 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.

Source page: https://510kreport.com/device/K213998
Methodology: https://510kreport.com/methodology