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Found 3 results
510(k) Data Aggregation
K Number
K111833Device Name
VIRTUE
Manufacturer
DIAGNOSOFT, INC.
Date Cleared
2011-09-21
(85 days)
Product Code
LLZ
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
DIAGNOSOFT, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Virtue software receives image data from medical scanning devices, such as CT or MRI, or from image archives and performs viewing, image manipulation, communication, printing and quantification of images.
Device Description
The Diagnosoft Virtue is software that runs on Windows-based operating systems to view and analyze MR images of the heart in DICOM format.
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K Number
K100352Device Name
DIAGNOSOFT HARP MODEL 2.06
Manufacturer
DIAGNOSOFT, INC.
Date Cleared
2010-03-11
(27 days)
Product Code
LNH
Regulation Number
892.1000Why did this record match?
Applicant Name (Manufacturer) :
DIAGNOSOFT, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Diagnosoft, Inc. HARP 2.06 is a stand-alone software package which provides the capability to review, analyze, and report on magnetic resonance (MR) images. HARP can import images from an MR system and display them in a viewing area on the computer screen. Images can be organized and displayed by study and series and organized into three-dimensional and temporal (multi-phase) collections. Temporal sequences can be displayed in a cine mode to facilitate visualization.
Tagged MR images can be imported, displayed and analyzed. Available measurements include displacement, twist, and radial, circumferential, and principle strains. Tools are provided for display of regional motion properties of the heart.
A report interface is provided. Measurement tools provide information that can be output in standardized or specialized report formats. This interface makes it possible to quickly and reliably fill out a complete clinical report of an imaging exam. The results of the measurement tools are interpreted by the physician and can be communicated to referring physicians in supporting the determination of a diagnosis.
Device Description
The Diagnosoft, Inc. HARP 2.06 is intended for the quantification of regional and global cardiac function from magnetic resonance images. It includes a user friendly implementation of the HARP methods for fast and reproducible measuring of myocardial motion and strain in the heart. With a friendly graphic user interface, users are able to analyze tagged MR images in minutes and produce many measurements including strain, torsion, and regional wall thickening.
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K Number
K061368Device Name
DIAGNOSOFT HARP
Manufacturer
DIAGNOSOFT, INC.
Date Cleared
2006-07-28
(73 days)
Product Code
LNH
Regulation Number
892.1000Why did this record match?
Applicant Name (Manufacturer) :
DIAGNOSOFT, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
DIAGNOSOFT HARP is a stand-alone software package which provides the capability to review, analyze, and report on magnetic resonance (MR) images. HARP can import images from an MR system and display them in a viewing area on the computer screen. Images can be organized and displayed by study and series and organized into three-dimensional and temporal (multi-phase) collections. Temporal sequences can be displayed in a cine mode to facilitate visualization.
Tagged MR images can be imported, displayed, and analyzed. Available measurements include displacement, twist, and radial, circumferential, and principle strains. Tools are provided for display of regional motion properties of the heart.
A report interface is provided. Measurement tools provide information that can be output in standardized or specialized report formats. This interface makes it possible to quickly and reliably fill out a complete clinical report of an imaging exam. The results of the measurement tools are interpreted by the physician and can be communicated to referring physicians in supporting the determination of a diagnosis.
Device Description
DIAGNOSOFT HARP is a stand-alone software package, designed for the Microsoft Windows operating system, providing the capability to import, display, and analyze magnetic resonance images of the heart. HARP imports DICOM images containing anatomical MRI, tagged MRI, perfusion MRI, or delayed enhancement MRI and is independent of the MR scanner manufacturer. HARP is intended to support clinicians in the diagnosis of heart disease.
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