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For In Vitro Diagnostic Use Sectra Digital Pathology Module (3.3) is a software device intended for viewing and management of digital images of scanned surgical pathology slides prepared from formalin-fixed paraffin embedded (FFPE) tissue. It is an aid to the pathologist to review and interpret these digital images for the purposes of primary diagnosis. Sectra Digital Pathology Module (3.3) is not intended for use with frozen section, cytology, or non-FFPE hematopathology specimens. It is the responsibility of the pathologist to employ appropriate procedures and safeguards to assure the validity of the interpretation of images using Sectra Digital Pathology Module (3.3). Sectra Digital Pathology Module (3.3) is intended for use with Leica's Aperio GT 450 DX scanner and Dell U3223QE display, for viewing and management of the ScanScope Virtual Slide (SVS) and Digital Imaging and Communications in Medicine (DICOM) image formats.

The Sectra Digital Pathology Module (3.3) [henceforth referred to DPAT (3.3)] is a digital slide viewing system. The DPAT (3.3) is intended for use together with FDA-cleared whole-slide image scanner GT 450 DX and Dell U3223QE display. The DPAT (3.3) can only be used as an add-on module to Sectra PACS. Sectra PACS consists of Sectra Workstation IDS7 (K081469) and Sectra Core (identified as a Class I exempt by the FDA in 2000). Sectra PACS is not part of the subject device. Sectra Workstation is the viewing workstation in which the Pathology Image Window is run. Pathology Image Window is the client component of the subject device. The system capabilities include: - retrieving and displaying digital slides, - support for remote intranet access over computer networks, - tools for annotating digital slides and entering and editing metadata associated with digital slides, and - displaying the scanned slide images for primary diagnosis by pathologists. The subject device is designed to accurately display colors. The monitor is not part of the subject device. Digital pathology images originating from WSI scanners other than those listed in the Indications for Use will be marked with the disclaimer "For Non-clinical Use Only" in the Pathology Image Window. Image acquisition will be managed by the scanner which is not part of the subject device: - The scanner delivers images with a tag in the file header that identifies the originating scanner. - The scanner includes applications for controlling the scanning process and performing related quality control (e.g., ensuring that images are sharp and cover all tissue on the slide). The DPAT (3.3) supports reading digital slides on a Dell U32230E display monitor, enabling pathologists to make clinically relevant decisions analogous to those they make using a conventional microscope. Specifically, the system supports the pathologist in performing a primary diagnosis based on viewing the digital slide on a computer monitor. These capabilities are provided by the Pathology Image Window.

For In Vitro Diagnostic Use Sectra Digital Pathology Module device is a software intended for viewing and management of digital images of scanned surgical pathology slides prepared from formalin-fixed paraffin embedded (FFPE) tissue. It is an aid to the pathologist to review and interpret these digital images for the purposes of primary diagnosis. Sectra Digital Pathology Module is not intended for use with frozen section, cytology, or non-FFPE hematopathology specimens. It is the responsibility of the pathologist to employ appropriate procedures and safeguards to assure the validity of the interpretation of images using Sectra Digital Pathology Module. Sectra Digital Pathology Module is intended for use with Leica's Aperio AT2 DX scanner and Dell MR2416 monitor.

Sectra Digital Pathology Module is a software-only device running under the Microsoft Windows operating system for displaying and manipulating digital pathology images (scanned slides) obtained from the Aperio AT2 DX scanner. Sectra Digital Pathology Module may only be used in combination with Sectra PACS which consists of Sectra Workstation (K081469) and Sectra Core (identified as a Class I exempt by the FDA in 2000). The Sectra Pathology Import Server (SPIS) is used for importing digital pathology images (scanned slides) from the scanner. These images are viewed and manipulated by end users in the Pathology Image Window which is displayed on the Sectra Workstation IDS7 (using the Dell MR2416 monitor).

The Sectra Angiography and Cardiology Package provides quantitative and reproducible information regarding the calculated dimensions of arterial segments, and quantitative information regarding the calculated dimensions and calculated performance characteristics of the left vertical of the heart, imaged during angiographic x-ray procedures typically performed in cath labs. This information is suitable for use in the following applications: 1. Scientific and research studies, assessing the angiographic condition of patients and the result of device and drug therapeutics, 2. Review and analysis of patient angiographic imaging records, providing additional information to physicians and administrators.

Sectra Angiography and Cardiology Package is intended to support radiologists and cardiologists in the diagnostic process to quantify findings. The device has functionality for quantitative analysis of the arteriograms (QCA and QVA) and quantitative analysis of the left ventricular angiographic images (LVA). Measurements can be applied on angiographic images.

The Sectra IDS device is intended for the manipulation and displaying of x-ray images. It can show images from different modalities and interfaces to various image storage and printing devices using DICOM or similar interface standards. Device options make possible telecommunications; fast demonstration; prosthesis CAD; 3-D and angiography, etc .; and teleconferencing. Typical users of this system are trained professionals, including but not limited to physicians, radiologists, nurses, medical technicians, and assistants.

The IDS5 10.1 Radiology Workstation is mainly a software product. It is used for visualization and processing of digital radiology images. The system runs under the Window 2000 and Windows XP operating system. The requirements on hardware are quite ordinary for a system used for displaying images. Most notably up to four monitors can be used.