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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device radiological software system for delivery date prediction
Definition A radiological software system for delivery date prediction is a software-only device that analyzes obstetric radiological images to predict the delivery date of a pregnancy. The device output does not replace a clinician's review or judgment on the progression of a pregnancy and should be used in conjunction with other clinical and diagnostic findings. The device does not identify at-risk pregnancies or identify specific complications.
Product CodeSHE
Regulation Number 892.8200
Device Class 2


Premarket Reviews
ManufacturerDecision
ULTRASOUND AI
  GRANTED 1

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