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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device digital pathology image viewing and management software
Definition 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.
Product CodeQKQ
Regulation Number 864.3700
Device Class 2


Premarket Reviews
ManufacturerDecision
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SECTRA AB
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