LEICA BIOSYSTEMS IMAGING, INC

GUDID#

Aperio HALO AP DX - Aperio HALO AP DX, version 2.4 (abbreviated as v2.4) is an image and case management browser-based software with an integrated image viewer. It is used within a pathology laboratory to organize and present scanned whole slide images for a patient’s case to the intended users. The user can then open specific slide images from the case and view, manipulate, and annotate the images on the diagnostic display monitor
LEICA BIOSYSTEMS IMAGING, INC
2026-10-26
Aperio GT 180 DX - Aperio GT 180 DX scanner is a WSI system comprised of an image acquisition subsystem known as the Aperio GT 180 DX scanner and Aperio WebViewer DX image viewing software which is accessed from a workstation and a display.
LEICA BIOSYSTEMS IMAGING, INC
2026-10-22
Aperio iQC DX Software - Aperio iQC DX Software is an artificial intelligence-based software intended to be used as an aid in the identification of artifacts in scanned whole slide images (WSIs) of hematoxylin and eosin (H&E) and immunohistochemistry (IHC) stained, formalin-fixed paraffin embedded (FFPE) tissue that should undergo further evaluation for image quality prior to diagnostic review of the images by pathologists.
LEICA BIOSYSTEMS IMAGING, INC
2026-10-22
Aperio AT2 DX Scanner - The Aperio AT2 DX System is composed of the Aperio AT2 DX scanner, the ImageScope DX review application and display. The Aperio AT2 DX System is for creation and viewing of digital images of scanned glass slides that would otherwise be appropriate for manual visualization by conventional light microscopy. It is the responsibility of a qualified pathologist to employ appropriate procedures and safeguards to assure the validity of the interpretation of images obtained using the Aperio AT2 DX System.
LEICA BIOSYSTEMS IMAGING, INC
2020-01-23
eIHC IVD bundle CS2- 2500 - The Aperio ePathology elHC IVD System is an automated digital slide creation, management, viewing and analysis system. It is intended for in vitro diagnostic use as an aid to the pathologist in the display, detection, counting and classification of tissues and cells of clinical interest based on particular color, intensity, size, pattern and shape. The IHC ER Image Analysis application is intended for use as an aid to the pathologist in the detection and quantitative measurement of ER (Estrogen Receptor) in formalin-fixed paraffin-embedded neoplastic tissue. The IHC PR Image Analysis application is intended for use as an aid to the pathologist in the detection and quantitation measurement of PR (Progesterone Receptor) in formalin-fixed, paraffin-embedded neoplastic tissue. It is indicated for use as an aid in the management, prognosis, and prediction of therapy outcomes of breast cancer.
LEICA BIOSYSTEMS IMAGING, INC
2016-09-19
eIHC IVD bundle AT Turbo-2500 - The Aperio ePathology elHC IVD System is an automated digital slide creation, management, viewing and analysis system. It is intended for in vitro diagnostic use as an aid to the pathologist in the display, detection, counting and classification of tissues and cells of clinical interest based on particular color, intensity, size, pattern and shape. The IHC ER Image Analysis application is intended for use as an aid to the pathologist in the detection and quantitative measurement of ER (Estrogen Receptor) in formalin-fixed paraffin-embedded neoplastic tissue. The IHC PR Image Analysis application is intended for use as an aid to the pathologist in the detection and quantitation measurement of PR (Progesterone Receptor) in formalin-fixed, paraffin-embedded neoplastic tissue. It is indicated for use as an aid in the management, prognosis, and prediction of therapy outcomes of breast cancer.
LEICA BIOSYSTEMS IMAGING, INC
2016-09-19
Aperio GT 450 DX (US) Scanner - Aperio GT 450 DX scanner is a WSI system comprised of an image acquisition subsystem known as the Aperio GT 450 DX scanner and Aperio WebViewer DX image viewing software which is accessed from a workstation and a display.
LEICA BIOSYSTEMS IMAGING, INC
2024-05-31