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ProFound Detection V4.0 is a computer-assisted detection and diagnosis (CAD) software device intended to be used concurrently by interpreting physicians while reading digital breast tomosynthesis (DBT) exams from compatible DBT system detects soft tissue densities (masses, architectural distortions and asymmetries) and calcifications in the 3D DBT slices. The detections and Certainty of Finding and Case Scores assist interpreting physicians in identifying soft tissue densities and calcifications that may be confirmed or dismissed by the interpreting Physician.

ProFound Detection V4.0 is a computer-assisted detection and diagnosis (CAD) software device that detects malignant soft-tissue densities and calcifications in digital breast tomosynthesis (DBT) images. The ProFound Detection V4.0 software allows an interpreting physician to quickly identify suspicious soft tissue densities and calcifications by marking the detected areas in the tomosynthesis images. When the ProFound Detection V4.0 marks are displayed by a user, the marks will appear as overlays on the tomosynthesis images. Each detected finding will also be assigned a "score" that corresponds to the ProFound Detection V4.0 algorithm's confidence that the detected finding is a cancer (Certainty of Finding). Certainty of Finding scores are a percentage in range of 0% to 100% to indicate CAD's confidence that the finding is malignant. ProFound Detection V4.0 also assigns a score to each case (Case Score) as a percentage in range of 0% to 100% to indicate CAD's confidence that the case has malignant findings. The higher the Certainty of Finding or Case Score, the higher the confidence that the detected finding is a cancer or that the case has malignant findings.

PowerLook Density Assessment is a software application intended for use with digital breast tomosynthesized 2D images from tomosynthesis exams. PowerLook Density Assessment provides an ACR BI-RADS Atlas 5th Edition breast density category to aid health care professionals in the assessment of breast tissue composition. PowerLook Density Assessment produces adjunctive information. It is not a diagnostic aid.

PowerLook Density Assessment 4.0 is a software application intended for use with mammography exams containing synthetic 2D images generated from Digital Breast Tomosynthesis (DBT) data. The PowerLook Density Assessment software assesses breast tissue composition and provides a breast density category aligned with BI-RADS® 5th Edition density lexicon. The PowerLook Density Assessment 4.0 algorithm is designed to be used with cases containing up to four synthetic 2D views. When exams contain only DBT and synthetic 2D images generated from DBT, the 4.0 algorithm is used. The PowerLook Density Assessment software is designed to work in conjunction with iCAD's PowerLook DICOM server platform, which is a Class I exempt medical device. The PowerLook Density Assessment 4.0 utilizes data management capabilities of PowerLook for controlling input to and output from the PowerLook Density Assessment algorithm. Results of the PowerLook Density Assessment software application can be displayed on a mammography review workstation, mammography reporting application or radiology information system (RIS), or printed case report.

The Axxent Cervical Applicator is indicated for use with the Axxent Electronic Brachytherapy System to deliver high dose rate brachytherapy for intracavitary treatment of cancer of the uterus, cervix, endometrium and vagina.

The Axxent Cervical Applicator is a component of the Axxent Electronic Brachytherapy System (cleared under K122951) which utilizes a proprietary miniaturized X-ray source and does not require radioactive isotopes. The applicator allows the Axxent HDR X-ray source to deliver high-dose rate, low energy radiation treatment to the uterus, cervix, endometrium and vagina. The Axxent HDR X-ray source mimics the penetration and dose characteristics of Iridium-192. The Axxent Cervical applicator is provided non-sterile and can be reused. The user must sterilize the device using steam sterilization before each use. An Applicator Clamp is a required accessory to stabilize the Cervical Applicator during radiation treatment.

The Axxent® Electronic Brachytherapy System is a high dose rate Brachytherapy device for use with Axxent Applicators to treat lesions, tumors and conditions in or on the body where radiation is indicated.

The Axxent Electronic Brachytherapy System consists of three primary components: the Axxent System Controller (Controller); the Axxent HDR X-ray Source-2.2 (Source); and an Axxentcompatible applicator (Applicator). The System is designed to deliver doses of X-ray radiation to the tissue in proximity to the applicator using a disposable, miniature X-ray tube powered by the Controller. The Axxent Electronic Brachytherapy Controller is a mobile, computer-controlled platform that is responsible for the overall operation of the System. The Controller is designed to work with the Source, which is a disposable, miniature X-ray tube located at the end of a flexible cable. The Source is inserted into a lumen of the appropriate Applicator.

The VersaVue™ Enterprise Suite consists of the MR Analysis Server software and the VersaVue Enterprise Workstation software. The MR Analysis Server software, which includes the SpectraLook®, VividLook® and OmniLook modules is intended to be used as a post-processing software package designed to provide a reliable means for analyzing MR datasets. The software facilitates the analysis of dynamic and non-dynamic MR datasets to provide study review and additional mathematical and/or statistical analysis. The resulting analysis can be displayed in a variety of formats, including parametric images overlaid onto source MRI images. The VersaVue Enterprise Workstation software is intended for use in conjunction with the MR Analysis Server software and facilitates the analysis and presentation of datasets generated by the MR Analysis Server software and incorporates the following functions: Region of Interest (ROI) curve, Pixel of Interest (POI) curve, Report Card, Volume Calculation, Statistical Analysis, 3-D visualization of image series, and DICOM reporting, among other capabilities. The VersaVue Enterprise Suite serves as a workflow roadmap tool that organizes and guides the radiologist through the series of sequential tasks that must be performed in order to arrive at a diagnosis. The specific configuration of product features drives the Suite's underlying workflow solution for lesion characterization and reporting. This inherent workflow regimen integrates easily into the radiologist's existing departmental workflow and can be adapted to fit the needs of each user, thereby streamlining diagnosis. In the hands of a trained physician the information provided by the data analysis could yield information that may assist in the interpretation of dynamic and non-dynamic MR studies.

The VersaVue Enterprise Suite is intended for post-processing of MR datasets to provide a reliable means for visualizing MR datasets and supports the evaluation of dynamic and non-dynamic MRI datasets. It is also designed to provide study review and mathematical. and/or statistical analysis. The VersaVue Enterprise Suite serves as a workflow roadmap tool that organizes and guides the radiologist through the series of sequential tasks that must be performed in order to arrive at a diagnosis. The VersaVue Enterprise Suite consists of the following two products; each product in turn incorporates individual modules: 1. MR Analysis Server Software_consists of: - SpectraLook, for Breast MR analysis . - VividLook, for Prostate MR analysis . - OmniLook, for analysis of other MR datasets . - 2. VersaVue Enterprise Workstation Software - PrecisionPoint, for MR Breast Interventional Planning (K090223) o The MR Analysis Server Software is intended to be used as a post-processing software package designed to provide a reliable means for visualizing MR data. The data analysis supports the evaluation of dynamic and non-dynamic MR datasets. The MR Analysis Server software also analyzes contrast enhanced magnetic resonance imaging (DCE-MRI) studies. The resulting information can be displayed in a variety of formats, including a parametric image overlaid onto source MR images. In the hands of a trained. physician the information provided by the software yields information that may assist in the interpretation of dynamic contrast enhanced studies. The VersaVue Enterprise Workstation Software is intended for use in conjunction with SpectraLook, VividLook and OmniLook MR post-processing analysis software to provide study review and additional mathematical and/or statistical analysis. The Workstation software does not change the SpectraLook, VividLook or OmniLook software algorithm or the image series produced by the algorithm. It supports the analysis and presentation of the original MR datasets and the results generated by the software algorithm and incorporates the following functions: Region of Interest (ROI) curve, Pixel of Interest (POI) curve, Report Card, Volume Calculation, Statistical Analysis, 3-D visualization of image series, and DICOM reporting, among other capabilities. The Workstation software also works with iCAD's PrecisionPoint Breast Interventional biopsy software. The Breast Interventional Planning Software cleared under K090223 integrates intervention planning ability into the existing iCAD viewing workstation, allowing physicians to read images followed by subsequent planning of MRI-guided percutaneous breast biopsies and other interventional procedures. Biopsy planning, puidance and all necessary documentation are generated through the same Workstation interface.

iCAD's VeraLook™ CTC CAD is intended to automatically detect potential polyps in CT Colonography exams. The identified polyps can then be highlighted to the interpreting physician after initial review of the CTC exam with the intent of identifying additional potential polyps that may not have been identified on initial review.

The VeraLook is a software-based CAD system for detecting the location and extent of polyps in CTC exams. The product is intended to receive CTC images in standard DICOM format from any 3D workstation manufacturer, perform automated analysis on the images to identify polyps, and then produce information about the identified regions that can be received and displayed by CTC review workstations to help radiologists in the detection of polyps.

The iCAD Breast Interventional Planning Software supports the use of interventional breast coils and MR stereotactic localization devices to perform magnetic resonance (MR) guided breast interventional procedures. Using information from MR images regarding the coordinates of a user-specified region of interest, and fiducial coordinates. the software provides an automatic calculation of the location and depth of the targeted region of interest, such as a lesion or suspected lesion relative to the interventional device.

The iCAD Breast Interventional Planning Software (BIPS) is intended to extract certain image information and display them to a user. The software allows the user to select a target lesion in the breast as well as fiducial markers, and get accurate information about the optimal positioning of the biopsy needle or other interventional device, including visualization of the appropriate position, distances and other applicable settings. iCAD's BIPS is a software tool, which can assist the radiologist in planning and performing MRI guidance of percutaneous breast biopsies and other interventional procedures. When interpreted by a skilled physician, this device provides information that may be useful in interventional planning and monitoring. The BIPS is a DICOM 3.0 compliant post-processing software package for viewing magnetic resonance imaging (MRI) data sets and supporting interventional breast coils and MR stereotactic localization devices when performing MRI-guided breast interventional procedures.