SUITEHEART
NEOSOFT, LLC
NEOSOFT, LLC
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3005914761 | 3005914761 | NEOSOFT, LLC | 1 | N | 2026-01-01 | N27W23910A Paul Road Pewaukee WI US 53072 |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 159074 | 2034442622 | K130228 | SUITEHEART | LLZ | 2013-03-20 |
| 159074 | 1163021267 | K080196 | Z3D CONTRAST ACUITY | LLZ | 2008-09-05 |
Product Codes Associated With Registrations#
| Product code | Registration listing records | Latest decision |
|---|---|---|
| LLZ | 2 | 2013-03-20 |
PMN#
GUDID#
suiteHEART - 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 software 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.
2018-11-21
suiteHEART - 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 software 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.
2019-07-15
suiteHEART - suiteHEART® Software is intended to assist trained clinical personnel in the qualification and quantification of cardiacfunction. The software provides the tools to adjust the parameters of the DICOM images and provides presentation stateswhere 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.
2018-05-29
CAKE - 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.
2018-08-01
suiteHEART - suiteHEART® Software is intended to assist trained clinical personnel in the qualification and quantification of cardiacfunction. The software provides the tools to adjust the parameters of the DICOM images and provides presentation stateswhere 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.
2016-05-23
suiteHEART - suiteHEART® Software is intended to assist trained clinical personnel in the qualification and quantification of cardiacfunction. The software provides the tools to adjust the parameters of the DICOM images and provides presentation stateswhere 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.
2016-11-23
suiteHEART - suiteHEART® Software is intended to assist trained clinical personnel in the qualification and quantification of cardiacfunction. The software provides the tools to adjust the parameters of the DICOM images and provides presentation stateswhere 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.
2017-01-24
suiteHEART - suiteHEART® Software is intended to assist trained clinical personnel in the qualification and quantification of cardiacfunction. The software provides the tools to adjust the parameters of the DICOM images and provides presentation stateswhere 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.
2017-05-30
suiteHEART - suiteHEART® Software is intended to assist trained clinical personnel in the qualification and quantification of cardiacfunction. The software provides the tools to adjust the parameters of the DICOM images and provides presentation stateswhere 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.
2017-07-24
suiteHEART - suiteHEART® Software is intended to assist trained clinical personnel in the qualification and quantification of cardiacfunction. The software provides the tools to adjust the parameters of the DICOM images and provides presentation stateswhere 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.
2017-11-13