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Whole Slide Imaging System

FDA product code PSY · 22 cleared devices

Class 2 Pathology
Regulation
21 CFR 864.3700
Review panel
PA
Implant
No
Life sustaining
No
Third party review
No
GMP exempt
No
Clearance span
2017-10-04 – 2026-08-07

The whole slide imaging system is an automated digital slide creation, viewing, and management system intended as an aid to the pathologist to review and interpret digital images of surgical pathology slides prepared from formalin-fixed, paraffin-embedded (FFPE) tissue. The system generates digital images that would otherwise be appropriate for manual visualization by conventional brightfield microscopy. The whole slide imaging system is not intended for use with slides prepared from frozen tissue, cytology, and non-FFPE hematopathology specimens (e.g., peripheral blood smear).

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