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510(k) Data Aggregation
K Number
K241922Device Name
Myomics
Manufacturer
Date Cleared
2025-02-28
(242 days)
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
Phantomics Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Myomics is intended to be used for viewing, post-processing, qualitative 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 cardiovascular MR images, for the purpose of obtaining diagnostic information as part of a comprehensive diagnostic decision-making process.
Device Description
Myomics is a software application for analysis cardiovascular MR images in DICOM Standard format. The software can be used as a stand-alone product that can be integrated into a hospital or private practice environment. This device has a graphical user interface which allows users to analyze cardiovascular MR images qualitatively and quantitatively.
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K Number
K211432Device Name
Myomics Q
Manufacturer
Date Cleared
2021-11-23
(200 days)
Product Code
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
Phantomics Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended 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 compliance assessment, document and follow up heart disease by cardiac MRI.
It shall be used by qualified medical professionals, experienced in examining 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.
Device Description
Myomics Q is software application for evaluating cardiovascular images in a DICOM Standard format. The software can be used as a stand-alone product that can be integrated into a hospital or private practice environment. This device has a graphical user interface which allows users to analyze cardiac MR Images qualitatively and quantitatively.
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Ask a specific question about this device
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