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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device automated radiological image processing software
Regulation Description Picture archiving and communications system.
Definition To provide automated radiological image processing and analysis tools. Software implementing artificial intelligence including nonadaptive machine learning algorithms trained with clinical and/or artificial data. In these devices, the algorithm training data typically impacts device performance. Adaptive AI algorithms are not within scope of this product code.
Product CodeQIH
Regulation Number 892.2050
Device Class 2


Premarket Reviews
ManufacturerDecision
ARTERYS INC.
  SUBSTANTIALLY EQUIVALENT 1
DIA IMAGING ANALYSIS LTD
  SUBSTANTIALLY EQUIVALENT 2
PHILIPS MEDICAL SYSTEMS
  SUBSTANTIALLY EQUIVALENT 2
PHILIPS MEDICAL SYSTEMS INTERNATIONAL BV
  SUBSTANTIALLY EQUIVALENT 2
SIEMENS
  SUBSTANTIALLY EQUIVALENT 2
SIEMENS CAPITAL
  SUBSTANTIALLY EQUIVALENT 1
SIEMENS MEDICAL SOLUTIONS USA, INC.
  SUBSTANTIALLY EQUIVALENT 1

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