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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
Regulation Description Whole slide imaging system.
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
EIZO CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN BEACON DISPLAY TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1

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