# K082628: CMR42 Cardiac Mri Imaging System, 2.1.23

- Pathway: 510(k) (Traditional)
- Applicant: Circle Cardiovascular Imaging, Inc.
- Decided: Nov 20, 2008 after 72 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: 3 generations back to K940172 (1994). 5 ancestors in all.
12 later devices descend from it; 5 cite it directly.
0 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K994283: Mri- Magnetic Resonance Analytical Software System, Medis Medical Imaging Systems BV (2000) Summary page 2.
- K994282: Mri- Flow Analytical Software Package, Medis Medical Imaging Systems BV (2000) Summary page 2.

## Most influential descendants
- K213998: cvi42 Auto Imaging Software Application (2022), 7 descendants of its own
- K243038: Salix Central (2025), 1 descendant of its own
- K222854: iTFlow (2023), 1 descendant of its own
- K211432: Myomics Q (2021), 1 descendant of its own
- K251027: cvi42 Coronary Plaque Software Application (2025), 0 descendants of its own

## Indications for use
cmr 4 2 is intended to be used for viewing, post-processing and quantitative evaluation of cardiovascular magnetic resonance (MR) images in a Digital Imaging and Communications in Medicine (DICOM) Standard format. It enables; * Importing Cardiac MR Images in DICOM format * Supporting clinical diagnostics by qualitative analysis of the cardiac MR images using display functionality such as panning, windowing, zooming, navigation through series/slices and phases. * Supporting clinical diagnostics by quantitative measurement of the heart and adjacent vessels in cardiac MR 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 MR images. * Flow quantifications based on velocity encodes images It shall be used by qualified medical professionals, experienced in examining and evaluating cardiovascular MR images, for the purpose of obtaining diagnostic information as part of a comprehensive diagnostic decision-making process. cmr 42 is a software application that can be used as a stand-alone product or in a networked environment. The target population for the cmr 42 is not restricted, however the image acquisition by a cardiac magnetic resonance scanner may limit the use of the device for certain sectors of the general public. cmr 42 shall not be used to view or analyze images of any part of the body except the cardiac magnetic resonance images acquired from a cardiovascular magnetic resonance scanner.

Source page: https://510kreport.com/device/K082628
Methodology: https://510kreport.com/methodology