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Digital Pathology Image Viewing And Management Software

FDA product code QKQ · 15 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
2020-03-31 – 2026-08-07

Digital pathology image viewing and management software device is a software intended for viewing and management of digital images of scanned surgical pathology slides prepared from formalin-fixed paraffin embedded (FFPE) tissue. It is an aid to the pathologist to review and interpret these digital images for the purposes of primary diagnosis.

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