Search Results
Found 1 results
510(k) Data Aggregation
K Number
K211059Device Name
CereFlow V1.2
Manufacturer
Date Cleared
2023-03-31
(721 days)
Product Code
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
Translational MRI, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
CereFlow™ V1.2 is an image processing software package to be used by trained professionals including but not limited to physicians and medical technicians. The software runs on a standard "off-the-shelf" workstation and can be used to perform image viewing, processing, image collage and analysis of medical images. Data and images are acquired through DICOM compliant imaging devices and modalities.
CereFlow™ V1.2 provides visualization and automatic semi-quantification of Arterial Spin Labeling (ASL) data acquired from Magnetic Resonance Imaging (MRI) scanners at 1.5T and 3.0T.
CereFlow™ V1.2 is able to process single-delay and multi-delay ASL data to quantify multiple perfusion parameters (Cerebral Blood Flow/CBF, Arterial Transit Time/ATT), and exports the results of ASL image analysis as DICOM images and in a report.
Device Description
CereFlow™ V1.2 is a medical viewing, analysis and processing, Medical Image Management and Processing System software implemented in Java and Java tools, compliant with the DICOM standard and running on standard PC (Windows 10 64-bit). CereFlow™ V1.2 is intended for visualization and automatic semi-quantitative quantification of arterial spin labeling (ASL) data acquired from MRI scanners at 1.5T and 3.0T. CereFlow™ V1.2 is able to process single-delay and multi-delay ASL data to generate multiple perfusion parameters (Cerebral Blood Flow/CBF, Arterial Transit Time/ATT), and exports the results of ASL image analysis as DICOM images and in a report.
The software consists of three modules, namely the interface module, and the database module. The interface module is responsible for interacting with users and helping them to manage cases easily. The report module is responsible for processing raw DICOM images and calculating parameters to generate ATT/CBF images which can be exported as DICOM images and in a report. Image pre-processing includes sorting and checking files to ensure designated protocols are used, having a complete set of reference (MO) image and label/control images, and implementing motion correction. The calculation of CBF and ATT parameters is implemented using the standard one-compartment perfusion model recommended by the consensus ASL white paper and standard nonlinear iterative curve-fitting approach for multi-delay ASL data. For single-delay ASL data, CBF is calculated according to the standard one-compartment perfusion model recommended by the ASL white paper.
The database module is responsible for managing cases including storing, query and deleting case data. The software applies an arrange of quality control parameters to ensure the quality of acquired ASL data and processed results. These quality control parameters can also be exported as a report.
The entire workflow is processed locally, and the report module shall only allow raw ASL imaging data importing from DICOM CD-R only. CereFlow™ V1.2 is not interface with DICOM servers, MR scanners, or PACS over wired network. It is a standalone software application designed to run on a dedicated PC workstation.
Ask a Question
Ask a specific question about this device
Page 1 of 1