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STAGE works as a comprehensive brain imaging post-processing solution. The STAGE system consists of a client supplied dedicated computer with an ethernet connection to the client’s existing local network. The STAGE software will operate within a virtual machine environment (virtual STAGE module) on this dedicated computer. The computer receives DICOM data from a specific MRI 3D GRE scan protocol (i.e., the STAGE protocol) and then outputs back numerous DICOM datasets with different types of contrast to the PACS server. The data transfer is initiated by the user’s current DICOM viewing software. STAGE has been modified from the predicate to include CROWN, a white noise filtering algorithm intended to improve specific STAGE outputs. The following table provide a summary of the methodology for each output with an example image and technical comparison to the predicate.
Spintech, Inc.
2
Not in Commercial Distribution
- 00866463000441 ()
- MRI system application software
STAGE works as a comprehensive brain imaging post-processing solution. The STAGE system consists of a dedicated computer connected to the user’s local area network. The computer receives DICOM data from a specific MRI 3D GRE scan protocol (i.e. the STAGE protocol) and then outputs back numerous DICOM datasets with different types of contrast to wherever it received the files from (most likely a PACS server). The STAGE system will not contain any user interface. Instead, the data transfer will be initiated by the user’s current DICOM viewing software. The main method for user communication will be through DICOM output files that contain information in the image data. A method for remote connection to the STAGE computer will be included for updating and troubleshooting when an internet connection is available.
Spintech, Inc.
1.1
Not in Commercial Distribution
- 00866463000410 ()
- MRI system application software
The Decisio Health Patient Dashboard (“Patient Dashboard”) is a data aggregation and visualization software device. The Patient Dashboard is designed to display patient information, facility specific care protocols, and visual cues to care providers on a single display device. The Patient Dashboard is configured to receive patient data through the facility’s Electronic Medical Record system and display information to the user on a patient monitor, computer, or a mobile device. Data received through the EMR includes input from various sources within the hospital, including manually entered data into the EMR (e.g., laboratory data), vital signs monitors, ventilators, IV pumps, and Foley catheter devices. The data the Patient Dashboard receives are then stored, filtered, and displayed through the Patient Dashboard web browser application. The Patient Dashboard is customized to individual facility’s care as it is programmed with the facility’s treatment protocols, which dictate the information that is displayed relative to those protocols. The device performs automated calculations on patient data collected by third party devices based on approved clinical protocols at patient care facilities.
DECISIO HEALTH, INC.
2
In Commercial Distribution
- 00865683000309 ()
- Clinical management support software
suiteHEART® Software is intended to assist trained clinical personnel in the qualification and quantification of cardiac
function. The software provides the tools to adjust the parameters of the DICOM images and provides presentation states
where the user can appreciate various MRI acquired images of the heart and vasculature over time. Additionally, the soft‐
ware provides tools for measuring linear distances, areas, and volumes that can be used to quantify cardiac function.
Finally, the software provides the tools for volumetric flow measurements and the ability to calculate flow values.
NEOSOFT LLC
4.0.6
Not in Commercial Distribution
- 00864747000279 ()
- MRI system application software
suiteHEART® Software is intended to assist trained clinical personnel in the qualification and quantification of cardiac
function. The software provides the tools to adjust the parameters of the DICOM images and provides presentation states
where the user can appreciate various MRI acquired images of the heart and vasculature over time. Additionally, the soft‐
ware provides tools for measuring linear distances, areas, and volumes that can be used to quantify cardiac function.
Finally, the software provides the tools for volumetric flow measurements and the ability to calculate flow values.
NEOSOFT LLC
4.0.4
Not in Commercial Distribution
- 00864747000262 ()
- MRI system application software
suiteHEART® Software is intended to assist trained clinical personnel in the qualification and quantification of cardiac
function. The software provides the tools to adjust the parameters of the DICOM images and provides presentation states
where the user can appreciate various MRI acquired images of the heart and vasculature over time. Additionally, the soft‐
ware provides tools for measuring linear distances, areas, and volumes that can be used to quantify cardiac function.
Finally, the software provides the tools for volumetric flow measurements and the ability to calculate flow values.
NEOSOFT LLC
4.0.3
Not in Commercial Distribution
- 00864747000255 ()
- MRI system application software
suiteHEART® Software is intended to assist trained clinical personnel in the qualification and quantification of cardiac
function. The software provides the tools to adjust the parameters of the DICOM images and provides presentation states
where the user can appreciate various MRI acquired images of the heart and vasculature over time. Additionally, the soft‐
ware provides tools for measuring linear distances, areas, and volumes that can be used to quantify cardiac function.
Finally, the software provides the tools for volumetric flow measurements and the ability to calculate flow values.
NEOSOFT LLC
4.0.2
Not in Commercial Distribution
- 00864747000248 ()
- MRI system application software
NeoSoft’s CAKE product is a post-processing, productivity software package designed to assist radiologists in the analysis of dynamic breast MR images. The software provides image display, supplemental information and visual enhancement of time/intensity changes extracted from MR temporal datasets. Single or multi-slice datasets, using standard acquisition protocols, are used for input.
The results may be displayed as either a grayscale enhancement or a color overlay on the selected image. CAKE may perform additional functions to aid in the analysis and viewing of dynamic studies including registration of serial MR acquisitions, labeling of tissue types based upon user specified enhancement characteristics, visualization and quantification of lesion morphology in 3D, segmentation of tissues, multi-planar reformats, maximum intensity projections, image averaging, and subtractions.
When interpreted by a skilled physician, this device provides information that may be useful in screening and diagnosis. Patient management decisions should not be made based solely on the results of CAKE analysis.
NEOSOFT LLC
3.0.0
In Commercial Distribution
- 00864747000231 ()
- MRI system application software
suiteHEART® Software is intended to assist trained clinical personnel in the qualification and quantification of cardiac
function. The software provides the tools to adjust the parameters of the DICOM images and provides presentation states
where the user can appreciate various MRI acquired images of the heart and vasculature over time. Additionally, the soft‐
ware provides tools for measuring linear distances, areas, and volumes that can be used to quantify cardiac function.
Finally, the software provides the tools for volumetric flow measurements and the ability to calculate flow values.
NEOSOFT LLC
4.0.1
Not in Commercial Distribution
- 00864747000224 ()
- MRI system application software
suiteHEART® Software is intended to assist trained clinical personnel in the qualification and quantification of cardiac
function. The software provides the tools to adjust the parameters of the DICOM images and provides presentation states
where the user can appreciate various MRI acquired images of the heart and vasculature over time. Additionally, the soft‐
ware provides tools for measuring linear distances, areas, and volumes that can be used to quantify cardiac function.
Finally, the software provides the tools for volumetric flow measurements and the ability to calculate flow values.
NEOSOFT LLC
4.0.0
Not in Commercial Distribution
- 00864747000217 ()
- MRI system application software