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Intuition (also referred to as Aquarius Intuition) is a medical device comprised of two stand-alone software components: a server software backend (Intuition Server) which performs complex image post processing and client viewer software (Intuition Client Viewers) that provides a user interface, enabling the user to view medical image data and associated derived metadata. The Intuition client viewer/server software enables 2D/3D/4D (3D with the dimension of time) image review, volume rendering, communications, storage, reporting, and image post processing. The Intuition software is used with off-the-shelf hardware, including a computer, monitor, keyboard and mouse.
Intuition is comprised of six (6) separate client viewers: Intuition Client with Emergency Lung Docker, Intuition Thin Client, Intuition Review, Intuition EMV, Intuition Web Viewer, and Intuition Mobile.
Terarecon Inc.
Intuition04
In Commercial Distribution
- INTUITION04 ()
Intuition
- Radiology DICOM image processing application software
Parascript® AccuDetect® is a Computer-Aided Detection (CAD) software device intended to aid radiologists reading mammograms. It is a proprietary software application designed to process FFDM images. The digital mammography images are automatically analyzed to identify areas suspicious for possible soft tissue densities and/or calcifications. Results are displayed on a computer monitor for review by a radiologist. The radiologist is instructed to first review each case in the conventional manner and then re-examine the case utilizing the information supplied by the Parascript® AccuDetect system before making a final assessment for the case.
AccuDetect® is not a diagnostic device, as the CAD marks are intended to be used to assist only in detection and not in interpretation. Therefore, AccuDetect® can assist a radiologist in detecting areas of concern that would have been missed without its use, but if used properly it cannot cause a radiologist to miss areas of concern that would have been detected without AccuDetect®.
PARASCRIPT, LLC
7.0
In Commercial Distribution
- M760ACCFFDM00170 ()
ACCFFDM00170
- Radiology DICOM image processing application software
Parascript® AccuDetect® is a Computer-Aided Detection (CAD) software device intended to aid radiologists reading mammograms. It is a proprietary software application designed to process FFDM images. The digital mammography images are automatically analyzed to identify areas suspicious for possible soft tissue densities and/or calcifications. Results are displayed on a computer monitor for review by a radiologist. The radiologist is instructed to first review each case in the conventional manner and then re-examine the case utilizing the information supplied by the Parascript® AccuDetect system before making a final assessment for the case.
AccuDetect® is not a diagnostic device, as the CAD marks are intended to be used to assist only in detection and not in interpretation. Therefore, AccuDetect® can assist a radiologist in detecting areas of concern that would have been missed without its use, but if used properly it cannot cause a radiologist to miss areas of concern that would have been detected without AccuDetect®.
PARASCRIPT, LLC
6.1
In Commercial Distribution
- M760ACCFFDM00161 ()
ACCFFDM00161
- Radiology DICOM image processing application software
No Description
Arterys Inc.
CVM2
Not in Commercial Distribution
- B664CVM20 ()
- Radiology DICOM image processing application software
No Description
Arterys Inc.
AVM3
Not in Commercial Distribution
- B664AVM30 ()
- Radiology DICOM image processing application software
No Description
Arterys Inc.
AOM4
Not in Commercial Distribution
- B664AOM40 ()
- Radiology DICOM image processing application software
No Description
Arterys Inc.
AMM5
Not in Commercial Distribution
- B664AMM50 ()
- Radiology DICOM image processing application software
icobrain mr is intended for automatic labeling, visualization and volumetric quantification of segmentable brain structures from a set of MR images. This software is intended to automate the current manual process of identifying, labeling and quantifying the volume of segmentable brain structures identified on MR images.
icobrain mr consists of two distinct image processing pipelines: icobrain mr cross and icobrain mr long.
icobrain mr cross is intended to provide volumes from images acquired at a single timepoint
icobrain mr long is intended to provide changes in volumes between two images that were acquired on the same scanner, with the same image acquisition protocol and with same contrast at two different timepoints
The results of icobrain mr cross cannot be compared with the results of icobrain mr long.
icometrix NV
5.16
In Commercial Distribution
- B621ICOBRAINMR5X16Y0 ()
- Radiology DICOM image processing application software
icobrain mr is intended for automatic labeling, visualization and volumetric quantification of segmentable brain structures from a set of MR images. This software is intended to automate the current manual process of identifying, labeling and quantifying the volume of segmentable brain structures identified on MR images.
icobrain mr consists of two distinct image processing pipelines: icobrain mr cross and icobrain mr long.
icobrain mr cross is intended to provide volumes from images acquired at a single timepoint
icobrain mr long is intended to provide changes in volumes between two images that were acquired on the same scanner, with the same image acquisition protocol and with same contrast at two different timepoints
The results of icobrain mr cross cannot be compared with the results of icobrain mr long.
icometrix NV
5.15
In Commercial Distribution
- B621ICOBRAINMR5X15Y0 ()
- Radiology DICOM image processing application software
icobrain mr is intended for automatic labeling, visualization and volumetric quantification of segmentable brain structures from a set of MR images. This software is intended to automate the current manual process of identifying, labeling and quantifying the volume of segmentable brain structures identified on MR images.
icobrain mr consists of two distinct image processing pipelines: icobrain mr cross and icobrain mr long.
icobrain mr cross is intended to provide volumes from images acquired at a single timepoint
icobrain mr long is intended to provide changes in volumes between two images that were acquired on the same scanner, with the same image acquisition protocol and with same contrast at two different timepoints
The results of icobrain mr cross cannot be compared with the results of icobrain mr long.
icometrix NV
5.14
In Commercial Distribution
- B621ICOBRAINMR5X14Y0 ()
- Radiology DICOM image processing application software