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Enterprise Imaging Desktops when deployed as a departmental Picture Archiving and Communications System (PACS) provides an interface for the acquisition, display, digital processing, annotation, review, printing, storage and distribution of multimodality medical images, reports and demographic information for diagnostic purposes within the system and across computer networks. Enterprise Imaging Desktops are intended to be used by trained healthcare professionals including, but not limited to physicians, radiologists, orthopaedic surgeons, cardiologists, mammographers, technologists, and clinicians for diagnosis and treatment planning using DICOM compliant medical images and other healthcare data.

MPR, MIP and 3D rendering functionality allows the user to view image data from perspectives different from that in which it was acquired. Other digital image processing functionality such as multi-scale window leveling, image registration and segmentation can be used to enhance image viewing. Automatic spine labelling provides the capability to semi-automatically label vertebrae or disks.

As a comprehensive imaging suite, Enterprise Imaging Desktops integrates with servers, archives, Radiology Information Systems (RIS), Cardiology Information Systems (CIS), Hospital Information Systems (HIS), Electronic Patient Records (EPR), reporting and 3rd party applications for customer specific workflows.

Lossy compressed mammography images and digitized film images should not be used for primary image interpretation. Uncompressed or non-lossy compressed "for presentation" images may be used for diagnosis or screening on monitors that are FDA-cleared for mammographic use.

When deployed as a hospital-wide Solution (Enterprise Imaging for Multispecialty Departments), Agfa HealthCare's Enterprise Imaging Desktops provides order generation, image acquisition, quality control, image reading, reporting, and review workflows for departments that have no such systems available including (but not limited to) dermatology, ophthalmology, gastroenterology, dental and general hospital use.

AGFA HealthCare's Enterprise Imaging XERO Viewer is a software application used for reference and diagnostic viewing of multispecialty medical imaging and non-imaging data with associated reports and documents and, as such, fulfills a key role in the Enterprise Imaging solution. XERO Viewer enables healthcare professionals, including (but not limited to) physicians, surgeons, nurses, and administrators to receive and view patient images, documents and data from multiple departments and organizations within one multi-disciplinary viewer. XERO Viewer allows users to perform image manipulations (including window/level, markups, 3D visualization) and measurements.

When images are reviewed and used as an element of diagnosis, it is the responsibility of the trained physician to determine if the image quality is suitable for their clinical application. Lossy compressed mammography images and digitized film images should not be used for primary image interpretation. Uncompressed or non-lossy compressed "for presentation" images may be used for diagnosis or screening on monitors that are FDA-cleared for their intended use.

XERO Viewer can optionally be configured for Full Fidelity Mobile, which is intended for mobile diagnostic use, review and analysis of CR, DX, CT, MR, US, ECG images and medical reports. XERO Viewer Full Fidelity Mobile is not intended to replace full diagnostic workstations and should only be used when there is no access to a workstation. XERO Viewer Full Fidelity Mobile is not intended for the display of mammography images for diagnosis.

This premarket notification is for AFGA HealthCare's Enterprise Imaging - Vessel Tracking functionality. The Vessel Tracking functionality is available in both AGFA HealthCare's Enterprise Imaging Desktops product and Enterprise Imaging XERO Viewer product.

Enterprise Imaging is a standalone software device (SaMD). AGFA HealthCare Enterprise Imaging Vessel Tracking functionality provides the capability to automatically create vessel centrelines, read the contour points and angles as well as provide minimum and maximum diameter of cross sections.

AGFA HealthCare's Enterprise Imaging Desktops is a medical image management and processing system (MIMPS), product code LLZ, which provides an interface for the acquisition, display, digital processing, annotation, review, printing, storage and distribution of multimodality medical images, reports and demographic information for diagnostic purposes within the system and across computer networks.

AGFA HealthCare's XERO Viewer is a medical image management and processing system (MIMPS), product code LLZ, which is a web based software application used for reference and diagnostic viewing of multispecialty medical imaging and non-imaging data with associated reports and documents. XERO Viewer enables healthcare professionals to receive and view patient images, documents and data from multiple departments and organizations within one multi-disciplinary viewer.

AGFA HealthCare's Enterprise Imaging Vessel Tracking adds the following new functionality available in both AGFA HealthCare's Enterprise Imaging Desktops product and Enterprise Imaging XERO Viewer product: a vessel analysis tool that provides the capability to automatically create vessel centrelines that can be used to monitor and analyze the progression of vascular diseases.

Vessel tracking is new functionality not included in the previous 510(k) clearances for Enterprise Imaging Desktops and Enterprise Imaging XERO Viewer. The vessel tracking algorithm however was previously included in AGFA HealthCare's IMPAX Volume Viewing 3.0 510(k) primary predicate K133135. The new device is substantially equivalent to the primary predicate device's (K133135) vessel analysis functionality.

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