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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device calibration software for radiology displays
Regulation Description Radiologic quality assurance instrument.
Definition The software is intended to calibrate displays to meet quality criteria that enable their use in primary diagnostic radiology.
Product CodeSHN
Regulation Number 892.1940
Device Class 1


Premarket Reviews
ManufacturerDecision
APPLE, INC.
  SUBSTANTIALLY EQUIVALENT 1

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