# K211432: Myomics Q

- Pathway: 510(k) (Traditional)
- Applicant: Phantomics, Inc.
- Decided: Nov 23, 2021 after 200 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: 4 generations back to K940172 (1994). 6 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 8 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 5.

## Most influential descendants
- K241922: Myomics (2025), 0 descendants of its own

## Indications for use
Myomics Q is intended to be used for viewing, post-processing and analysis of cardiac 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 analysis of cardiac MR images using display functionality such as panning, windowing, zooming through series/slices of the images.* - Supporting clinical diagnostics analysis of the heart in cardiac MR images and signal intensity. - Software package is designed to support the physician-to-physician compliance assessment, document and follow up heart disease by cardiac MRI. 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. This device is a software application that can be used as a stand-alone product or in a network environment. The target population for the device is not restricted, however the image acquisition by a cardiac MR scanner may limit the use of the device for certain sectors or the public.

Source page: https://510kreport.com/device/K211432
Methodology: https://510kreport.com/methodology