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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device software algorithm device to assist users in digital pathology
Definition A software algorithm device to assist users in digital pathology is an in vitro diagnostic device intended to evaluate acquired scanned pathology whole slide images. The device uses software algorithms to provide information to the user about presence, location, and characteristics of areas of the image with clinical implications. Information from this device is intended to assist the user in determining a pathology diagnosis.
Product CodeQPN
Regulation Number 864.3750
Device Class 2


Premarket Reviews
ManufacturerDecision
PAIGE.AI
  GRANTED 1

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