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510(k) Data Aggregation
K Number
K222975Device Name
Advantis Platform
Manufacturer
Date Cleared
2023-03-01
(154 days)
Product Code
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
Advantis Medical Imaging Single Member P.C.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Advantis Platform provides analysis and visualization capabilities of dynamic MRI data of the brain and prostate, presenting the derived properties and parameters in a clinically useful context.
Advantis Platform is intended as a general medical image management and processing system. Advantis Platform is intended to be used by trained healthcare professionals and provides information that, in a clinical setting, may assist in the interpretation of brain and prostate MR studies of adult population.
Diagnosis should not be made solely based on the analysis performed using Advantis Platform.
Device Description
Advantis Platform is a web-accessible medical viewing and post-processing software application.
Advantis Platform offers comprehensive functionality for dynamic image analysis and visualization of brain and prostate MRI data which are acquired through DICOM-compliant imaging devices and modalities.
The main functionalities of Advantis Platform are listed below.
Brain MRI-related functionalities include:
- BOLD: BOLD fMRI analysis is used to highlight small magnetic susceptibility changes in the human brain in areas with altered blood flow resulting from neuronal activity.
- · DTI: Diffusion analysis is used to visualize local water diffusion properties from the analysis of diffusionweighted MRI data. Fiber tracking utilizes the directional dependency of the diffusion to display the white matter structure in the brain.
- DSC Perfusion: Calculations of perfusion-related parameters that provide information about the blood vessel structure and characteristics as a response of the brain to a specific contrast agent.
Prostate MRI-related functionalities include:
- · Diffusion-Weighted Imaging (DWI) processing: Diffusion analysis is used to visualize local water diffusion properties from the analysis of diffusion-weighted MRI data.
- · Dynamic Contrast-Enhanced Perfusion (DCE Perfusion) processing: Calculations of perfusion-related parameters that provide information about the tissue response to the injection of a contrast medium.
Advantis Platform, apart from the image processing and manipulation functions, provides a wide range of visualization tools, data handling, and reporting features.
- · Image uploading, storing, and exporting
- Data handling
- · Image viewing
- · Reporting feature
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K Number
K202808Device Name
Brainance MD
Manufacturer
Date Cleared
2021-10-14
(386 days)
Product Code
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
Advantis Medical Imaging Single Member P.C.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Brainance MD provides analysis and visualization capabilities of dynamic MRI data of the brain, presenting the derived properties and parameters in a clinically useful context.
Device Description
Brainance MD is a web-accessible medical viewing and post-processing software application. Brainance MD offers comprehensive functionality for dynamic image analysis and visualization of brain MRI data which are acquired through DICOM compliant imaging devices and modalities. The following algorithms provide the main functional analyses of the software application. BOLD: BOLD fMRI analysis is used to highlight small magnetic susceptibility changes in the human brain in areas with altered bloodflow resulting from neuronal activity. DTI: Diffusion analysis is used to visualize local water diffusion properties from the analysis of diffusion-weighted MRI data. Fiber tracking utilizes the directional dependency of the diffusion to display the white matter structure in the brain. DSC Perfusion: Calculations of perfusion related parameters that provide information about the blood vessel structure and characteristics. Examples of such maps are blood flow, time to peak, mean transit time and leakage. Apart from the aforementioned functionalities, Brainance MD offers general visualization tools, a data upload, data download and a reporting feature.
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