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510(k) Data Aggregation
K Number
K080196Device Name
Z3D CONTRAST ACUITY
Manufacturer
CLARIO MEDICAL IMAGING, INC.
Date Cleared
2008-09-05
(224 days)
Product Code
LLZ
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
CLARIO MEDICAL IMAGING, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Z3D Contrast Acuity (z3D) version 2.1 is a post-processing, productivity software package designed to assist radiologists in the analysis of dynamic CT and MR images. The software provides image display, supplemental information and visual enhancement of time/intensity changes extracted from CT and MR temporal datasets. Single or multi-slice datasets, using standard acquisition protocols, are used for input.
The software displays the temporal variation in dynamic data as a surface map that enhances visualization of pixel intensity and time/intensity changes extracted from CT and MR temporal data sets. The results may be displayed as either a grayscale enhancement or a color overlay overlay over the selected image.
z3D may perform additional functions to aid in the analysis and viewing of dynamic studies, including registration of serial MR and CT acquisitions, labeling of tissue types based upon user specified enhancement characteristics, visualization and quantification of lesion morphology in 310. segmentation of tissues, multiplanar and oblique reformats, maximum intensity projections, image, averaging, subtraction and blinking of images acquired at different time noints to help visualize enhancement.
23D also may be used to perform post-processing analysis of multi-modality, digital images, including MR, CT, X-Ray, PET, and Nuclear Medicine images. The software analysis tools may be anplied to image subtractions, reformatted images, multiplanar reformats, and maximum intensity projections.
The software package includes tools to allow the radiologist to manipulate and fly-through images for enhanced visualization.
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 z3D analysis. The z3D software is contraindicated for automated sole interpretation of digital mammography images.
Device Description
z3D Contrast acuity (z3D) Version 2.1 is a software package designed to assist the radiologist in interpretation of multi-modality, digital radiology images, including dynamic CT and MR image data sets. The software applies standard 2D and 3D image processing techniques on a pixel-bypixel basis to analyze grayscale data and perform visual enhancement of user-selected images. The software may be applied to image subtractions, reformatted images, multiplanar reformats, and Maximum Intensity Projections (MIP). Single or multi-slice data sets may be used as input.
The software consists of several modes that can be enabled or disabled depending upon the specific configuration purchased/implemented. These modes include 2D image review, 2D mass morphology, 3D mass characterization.
The results of the analysis are displayed as a surface man, parametric map, Maximum Intensity Projection (MIP), subtraction, registered subtraction, or 3D display that enhances visualization of pixel intensity data provided by the image. The results may be displayed in grayscale enhancement or as a color overlay. The software includes standard workflow tools that allow the radiologist to manipulate, rotate and fly-through images for enhanced visualization of the digital output. Additionally, the software package allows the radiologist to visually inspect time sensitive contrast agent intensity curves and to make mass measurements.
The software application consists of proprietary software developed by Clario and is a Windows 2000/XP, DICOM-compatible platform. The software is designed to be distributed as a plug-in for OEM imaging systems, PACS, workstations, or embedded in software applications cleared for use in medical imaging.
The z3D user interface is designed to follow typical workflow patterns to process, review, and analyze digital images.
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K Number
K052963Device Name
MEDIQ VERSION 1.0
Manufacturer
CLARIO MEDICAL IMAGING, INC.
Date Cleared
2005-12-05
(45 days)
Product Code
LLZ
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
CLARIO MEDICAL IMAGING, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
MedIQ is a post-processing, productivity software package designed to assist radiologists in the analysis of dynamic CT and MR images. The software provides supplemental information and visual enhancement of time/intensity changes extracted from CT and MR temporal datasets. Single or multi-slice datasets, using standard acquisition protocols, are used for input.
The software displays the temporal variation in dynamic data as a surface map that enhances visualization of pixel intensity and time/intensity changes extracted from CT and MR temporal data sets. The results may be displayed as either a grayscale enhancement or a color overlay on the selected image.
MedIQ also may be used to perform post-processing analysis of multimodality, digital images, including MR, CT, X-Ray, PET and Nuclear Medicine images. The software analysis tools may be applied to image subtractions, reformatted images, multiplanar reformats, and maximum intensity projections.
The software package includes tools to allow the radiologist to manipulate and fly-through images for enhanced visualization, and a z-axis kinematic motion feature.
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 MedIQ analysis. The MedIQ software is not intended for use for primary interpretation of digital mammography images.
Device Description
MedIQ Version 1.0 is a software package designed to assist the radiologist in interpretation of multi-modality, digital radiology images, including dynamic CT and MR image data sets. The software applies standard 2D and 3D image processing techniques on a pixel-by-pixel basis to analyze grayscale data and perform visual enhancement of user-selected images. The software may be applied to image subtractions, reformatted images, multiplanar reformats, and maximum intensity projections. Single or multi-slice data sets may be used as input.
The results of the analysis are displayed as a surface map that enhances visualization of pixel intensity data provided by the image. The results may be displayed in grayscale enhancement or as a color overlay. The software includes standard workflow tools that allow the radiologist to manipulate, rotate and fly-though images for enhanced visualization of the digital output.
The software application consists of proprietary software developed by Clario and is a Windows 2000/XP, DICOM-compatible platform. The software is designed to be distributed as an SDK or as an application for installation on DICOM-compatible OEM imaging systems, PACS, workstations, stand-alone PCs, or embedded in software applications cleared for use in medical imaging. The device also may be distributed by Clario as a stand-alone PC product.
The MedIQ user interface is designed to follow typical clinical workflow patterns to process, review, and analyze digital images.
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