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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device digital pathology display
Definition The digital pathology display device is intended for in vitro diagnostic use to display digital images of histopathology slides acquired from FDA-cleared whole-slide imaging scanners that are used for review and interpretation by trained pathologists.
Product CodePZZ
Regulation Number 864.3700
Device Class 2


Premarket Reviews
ManufacturerDecision
BARCO N.V.
  SUBSTANTIALLY EQUIVALENT 1

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