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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device ultrasound imaging system for acquiring images at home by lay users
Definition An ultrasound imaging system for acquiring images at home by lay users is a prescription home use device that may consist of hardware and/or software intended for acquiring ultrasound images for interpretation by a qualified health care professional (e.g., fetal images for determination of fetal heart rate). The device provides guidance to lay users to aid image acquisition.
Product CodeSGJ
Regulation Number 892.1590
Device Class 2


Premarket Reviews
ManufacturerDecision
PULSENMORE LTD.
  GRANTED 1

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