FDA Radiology AI Devices

Discover FDA-cleared medical imaging AI devices with clean summaries, company insights, and linked references. We help you quickly understand what's approved, who built it, and how it fits into the evolving landscape of radiology AI.

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.

FDA #
K243871
Product Code
PSY

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.

FDA #
K241717
Product Code
PSY

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.

FDA #
K242783
Product Code
PSY

The Philips IntelliSite Pathology Solution 5.1 is a digital pathology system that automates scanning, managing, and viewing of glass pathology slides prepared from formalin-fixed paraffin embedded (FFPE) tissue. It aids pathologists by providing high-resolution digital images of tissue slides for diagnostic review, enhancing the workflow for interpretation compared to traditional microscopy.

FDA #
K242848
Product Code
PSY
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