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IntelePACS is a software application that receives digital images and data from various sources (such as, CT scanners, MR scanners, ultrasound systems, R/F units, computer and direct radiographic devices, secondary capture devices, scanners, imaging gateways, or other imaging sources). Images and data can be communicated, processed, manipulated, enhanced, stored, and displayed within the system and/or across computer networks at distributed locations. Postprocessing of the images can be performed using Multi Planar Reconstruction (MPR). Only preprocessed DICOM for presentation images can be interpreted for primary image diagnosis in mammographic images with lossy compression and digitized film screen images must not be reviewed for primary image interpretations. Mammographic images may only be interpreted using an FDA cleared display that meets technical specifications reviewed and accepted by FDA. When used with a mobile device, IntelePACS is suitable for diagnostic image review only on tested devices as specified in Intelerad product documentation. IntelePACS is not intended for primary diagnostic image review on mobile devices. Mobile usage for Mammography is for reference and referral only.

IntelePACS, (version 5), is based upon the predicate device IntelePACS, version 4.9.1 (K150707). Both the subject device and the predicate are from Intelerad Medical Systems Inc. IntelePACS is comprised of software modules that provide image capture, storage, distribution, enhancement, manipulation, and networking of medical images at distributed locations. In cases where DICOM images are not directly available to IntelePACS, the system can acquire medical images using a DICOM image gateway, which generates DICOM-type files. For example, film digitizers obtain images from original film and convert them to meet DICOM standards. Stored files are transmitted using a network and can be viewed or manipulated using InteleViewer viewing software. The main components are: - InteleViewer is an image viewing system, providing access to the tools required for reviewing images and searching to find studies and reports. InteleViewer features DICOM support, including DICOM Query/Retrieve, Store, and Print. The software module includes a thumbnail display, real-time cine playback, linked stacking, MPR, annotations and measurements, etc. The web-enabled InteleViewer software uses JPEG 2000 compression and an advanced streaming protocol to provide lossless or lossy image viewing and manipulation. The user can examine multiple studies simultaneously and define customized image layouts. With a mouse click, the User can stack, rotate, zoom, take measurements, and view reports. - InteleConnect Enhanced Viewer (used on Mobile Devices) is a web-based portal for medical images review that can be used on the desktop and on mobile devices without requiring software installation. This is a new module which is not in the Primary Predicate but is available in the Reference Predicate device. - InteleBrowser which is a web-based administrative interface for IntelePACS, and allows the facility System Administrator to customize and configure the facility radiological workflow and corporate branding. The System Administrator can administer hundreds or thousands of IntelePACS users by taking advantage of the user management and access granting tools.

IntelePACS™ is a device that receives digital images and data from various sources (such as, CT scanners, ultrasound systems, R/F units, computer and direct radiographic devices, secondary capture devices, scanners, imaging gateways, or other imaging sources). Images and data can be communicated, processed, manipulated, stored, and displayed within the system and/or across computer networks at distributed locations. Post-processing of the images can be performed using Multi Planar Reconstruction (MPR). Mammographic images may only be interpreted using an FDA cleared monitor that meets technical specifications reviewed and cleared by FDA. Typical users of this system are trained professionals, physicians, nurses, and technicians. Contraindications: Lossy compressed images and digitized film screen images must not be reviewed for primary image interpretations.

IntelePACS™ is comprised of software modules that provide image capture, storage, distribution, enhancement, manipulation, and networking of medical images at distributed locations. In cases where DICOM images are not directly available to IntelePACS™, the system can acquire medical images using a DICOM image gateway, which generates DICOM-type files. For example, film digitizers obtain images from original film and convert them to meet DICOM standards. Stored files are transmitted using a network and can be viewed or manipulated using InteleViewer viewing software.