Device typeDigital pathology image display unit IVD: An electrically-powered visual image display unit (VDU), commonly known as a screen or a monitor, with dedicated software specifically designed for displaying high-resolution digital histology/pathology images during in vitro diagnostic procedures. It is used in conjunction with an automated digital pathology scanner/microscope and is designed to display colours that are important in digital pathology (e.g., purples, pinks, magentas).
FDA categoryWhole Slide Imaging System
Device ID05415334055926
Catalog numberK9301101A2X
AvailabilityPrescription
MRI safetyLabeling does not contain MRI Safety Information