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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device image acquisition and/or optimization guided by artificial intelligence
Definition A radiological acquisition and/or optimization guidance system is a device that is intended to aid in the acquisition and/or optimization of images and/or diagnostic signals. The device interfaces with the acquisition system, analyzes its output, and provides guidance and/or feedback to the operator for improving image and/or signal quality.
Product CodeQJU
Regulation Number 892.2100
Device Class 2


Premarket Reviews
ManufacturerDecision
BAY LABS, INC.
  GRANTED 1
CAPTION HEALTH
  SUBSTANTIALLY EQUIVALENT 2
ULTRASIGHT INC.
  SUBSTANTIALLY EQUIVALENT 1

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