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Device digital pathology image artifact detection software device
Regulation Description Whole slide imaging system.
Definition Digital Pathology Image Artifact Detection Software device is an artificial intelligence-based software intended to identify specific artifacts in scanned digital whole slide images (WSIs) of pathology slides prepared from human samples. It is intended to identify WSIs that should undergo further evaluation for image quality prior to diagnostic review of the images by pathologists. Device output is not intended for use in diagnosis, prognosis, or prediction of disease.
Product CodeSIX
Regulation Number 864.3700
Device Class 2


Premarket Reviews
ManufacturerDecision
LEICA BIOSYSTEMS IMAGING, INC.
  SUBSTANTIALLY EQUIVALENT 1

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