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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
Regulation Description Whole slide imaging system.
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
AETHERAI CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
INSPIRATA, INC.
  SUBSTANTIALLY EQUIVALENT 1
JELLOX BIOTECH INC.
  SUBSTANTIALLY EQUIVALENT 1
LUMEA, INC.
  SUBSTANTIALLY EQUIVALENT 1
PAIGE.AI, INC
  SUBSTANTIALLY EQUIVALENT 2
PATHAI, INC.
  SUBSTANTIALLY EQUIVALENT 2
PATHPRESENTER CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
SECTRA AB
  SUBSTANTIALLY EQUIVALENT 1
TRIBUN HEALTH
  SUBSTANTIALLY EQUIVALENT 1

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