Search Results
Found 1 results
510(k) Data Aggregation
K Number
K210415Device Name
QSM software, QSMetric
Manufacturer
Date Cleared
2021-07-22
(161 days)
Product Code
Regulation Number
892.1000Why did this record match?
Applicant Name (Manufacturer) :
Medimagemetric LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
QSM software (QSMetric™) is intended for use in the post-acquisition image enhancement of 3D MR images of the brain acquired using a gradient-echo sequence at 1.5T, 3T and 7T field strengths. QSM uses phase information to enhance contrast between tissues presenting magnetic susceptibility differences, such as deoxygenated blood, iron or calcium deposits. When used in combination with other clinical information, QSM may aid the qualified physicians in visualizing tissue structures with magnetic susceptibility contrasts and measuring their susceptibility values.
Device Description
The product QSMetric™, also referred to as QSM software, postprocesses gradient echo magnetic resonance (MR) images to depict tissue magnetic susceptibility contrast (local difference). Tissue susceptibility contrast sources include highly paramagnetic iron presented in deoxyhemoglobin, ferritin and hemosiderin, and diamagnetic calcification. Susceptibility contrast material of tissue in the MR scanner generates its own magnetic field according to the convolution law in magnetism. This tissue field with its dispersion in space causes MR image signal magnitude loss, creating contrasts in magnitude images. Therefore, the magnitude image is commonly used to indicate the presence of nearby tissue susceptibility contrast.
In addition to magnitude images, a gradient echo MR scan results in also phase images. The tissue field causes MR image signal phase accrual, creating contrasts in phase images. The phase image of gradient echo MR data is the product of echo time and tissue field. Accordingly, the phase images from a gradient echo MR scan is processed using QSM to enhance the depiction of tissue susceptibility contrasts.
QSM software works in conjunction with any FDA cleared third-party DICOM viewer as an image postprocessing solution in radiological service.
Ask a Question
Ask a specific question about this device
Page 1 of 1