FDA Radiology AI Devices

AISight Dx is a software-only, web-based digital pathology image viewing and management system designed to aid pathologists in viewing, interpreting, and managing digital images of scanned surgical pathology slides prepared from formalin-fixed paraffin embedded (FFPE) tissue. It supports images from scanners such as the Hamamatsu NanoZoomer S360MD and Leica Aperio GT 450 DX. The software allows pathologists to zoom, pan, measure, and annotate whole slide images to assist in primary diagnosis while ensuring image quality through built-in quality controls.

PathPresenter Clinical Viewer is a web-based software tool designed to help pathologists view and manage high-resolution digital images of tissue slides. It facilitates diagnosis by allowing detailed image navigation, annotation, and measurement, improving pathology workflow and accuracy.

The RadiForce MX317W-PA is a color LCD monitor designed for displaying digital images of histopathology slides acquired from whole-slide imaging scanners. It aids pathologists in the review and interpretation of these slides for primary diagnosis by providing high-quality image visualization with calibrated display modes and color accuracy.

CaloPix is a software-only digital pathology image management system designed to help pathologists view, interpret, and manage whole slide images from scanned surgical pathology slides of formalin-fixed paraffin embedded tissue. It supports detailed image review including panning, zooming, annotation and measurement and integrates with laboratory systems to organize pathology cases digitally. The software assists clinicians in efficiently handling large digital slide datasets to aid in primary diagnosis.

Viewer+ is an internet browser-based software intended to help pathologists view and manage digital images of scanned surgical pathology slides prepared from formalin-fixed paraffin embedded tissue. It aids in primary diagnosis by allowing image navigation, annotation, and measurement, ultimately supporting pathology evaluations digitally.

The Philips IntelliSite Pathology Solution 5.1 is an automated system that creates, views, and manages digital images of pathology slides prepared from tissue samples. It aids pathologists by providing digital visualization of glass slides, facilitating the review and interpretation of surgical pathology in a digital format, thus modernizing and streamlining pathology workflows.

The Epredia E1000 Dx Digital Pathology Solution is an automated system that creates, views, and manages digital images of surgical pathology slides prepared from formalin-fixed paraffin-embedded tissue. It helps pathologists interpret tissue samples digitally, providing an alternative to traditional light microscopy and improving workflow and diagnostic accuracy in pathology labs.

FullFocus is a web-based software that enables pathologists to view, navigate, and manage digital images of scanned surgical pathology slides prepared from FFPE tissue. It helps pathologists review images for primary diagnosis by providing tools like zooming, panning, measurement, and annotation, improving diagnostic workflow and accuracy.

The 8MP Color LCD Displays (models C811W, C811WT, PA27, PA27T) are high-resolution color LCD screens designed to display digital images of histopathology slides for primary diagnosis. They aid pathologists by providing stable, calibrated, and precise image visualization from validated whole-slide imaging systems, assisting in the interpretation of digital pathology images.

Roche Digital Pathology Dx is a digital slide scanning and management system designed to assist pathologists by creating, viewing, and managing high-resolution digital images of pathology slides prepared from formalin-fixed paraffin-embedded tissue. It includes slide scanners and software for image acquisition and management, enabling pathologists to review digital slides instead of traditional light microscopy.