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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device light based imaging
Definition Emission and collection of light to create an image for medical purposes
Product CodePSN
Regulation Number 878.4580
Device Class 2


Premarket Reviews
ManufacturerDecision
BARCO NV
  SUBSTANTIALLY EQUIVALENT 3
DEEPX HEALTH LLC
  SUBSTANTIALLY EQUIVALENT 1

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