Indications for use statementTopic number: 1425412988102

AGFA HealthCare Enterprise Imaging

AGFA HealthCare Enterprise Imaging Desktops when deployed as a departmental Picture Archiving and Communications System (PACS) provide 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 Enterprise Imaging Desktops are intended to be used by trained healthcare professionals including, but not limited to, physicians, radiologists, orthopedic 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 labeling provides the capability to semi-automatically label vertebrae or discs.

As a comprehensive imaging suite, AGFA HealthCare Enterprise Imaging Desktops integrate with servers, archives, Radiology Information Systems (RIS), Cardiology Information Systems (CIS), Hospital Information Systems (HIS), Electronic Patient Records (EPR), reporting and third-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 can be used for diagnosis or screening on monitors that are FDA-cleared for mammographic use.

When deployed as part of the AGFA HealthCare Enterprise Imaging Solution (AGFA HealthCare Enterprise Imaging for Multispecialty Departments), AGFA HealthCare Enterprise Imaging Desktops provide 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.

Integration with Citrix has not been validated for diagnostic use; it is the user’s responsibility to ensure that the Citrix configuration supports sufficient image quality for their purposes.

XERO Viewer indications for 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.