# K241922: Myomics

- Pathway: 510(k) (Traditional)
- Applicant: Phantomics, Inc.
- Decided: Feb 28, 2025 after 242 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: 8 generations back to K945512 (1995). 25 ancestors in all.
No later device cites it as a predicate yet.
0 of 26 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K211432: Myomics Q, Phantomics, Inc. (2021) Summary page 5.
- K213998: cvi42 Auto Imaging Software Application, Circle Cardiovascular Imaging, Inc. (2022) Summary page 5.

## Indications for use
Myomics is intended to be used for viewing, post-processing, qualitative and quantitative evaluation of cardiovascular magnetic resonance (MR) 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; and to view the presence or absence of physician-identified lesion in blood vessels. The target population for manual workflows of Myomics is not restricted; however, semi-automated machine learning algorithms of Myomics are intended for an adult population. The software comprises various analysis modules, including AI-powered algorithms, for a comprehensive evaluation of MR images. Myomics is used for cardiac images acquired from a 3.0 T MR scanner. Myomics shall be used only for cardiac images acquired from an MR scanner. 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.

Source page: https://510kreport.com/device/K241922
Methodology: https://510kreport.com/methodology