# K131158: Corview

- Pathway: 510(k) (Traditional)
- Applicant: Marrek, Inc.
- Decided: Aug 21, 2013 after 119 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: 13 generations back to K935595 (1995). 73 ancestors in all.
No later device cites it as a predicate yet.
0 of 74 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K120135: 2D Cardiac Performance Analysis MR 1.0, Tomtec Imaging Systems GmbH (2012) Summary page 1.
- K111833: Virtue, Diagnosoft, Inc. (2011) Summary page 1.

## Indications for use
The Corview software application is indicated for viewing and post-processing of cardiovascular magnetic resonance images (MRIs) to obtain Left Atrial Enhancement (LAE) quantification and visualization on a 3D model. It provides measurements of LAE within the left atrial wall. It enables: * Importing Cardiac MRIs in DICOM format * Qualitative analysis of the cardiac MRIs using display functionality such as panning, windowing, zooming, and navigation through series/slices and phases * Quantitative measurement in cardiac MRIs, specifically LAE It is intended for use by qualified medical professionals experienced in examining and evaluating cardiovascular MRIs, for the purpose of obtaining diagnostic information as part of a comprehensive diagnostic decision-making process. The target population of Corview is not restricted. However image acquisition by an MRI scanner with cardiac capability may limit the use of the device for certain sectors of the general public. Corview is intended to view only cardiac magnetic resonance images acquired from an MRI scanner with cardiac capabilities. The CORVIEW software application is intended for use in the clinical setting.

Source page: https://510kreport.com/device/K131158
Methodology: https://510kreport.com/methodology