Медицинские устройства; Exemption From Premarket Notification: Radiology Computer-Aided Detection and/or Diagnosis Devices and Computer-aided Triage and Notification Devices

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The Food and Drug Administration (FDA or Agency) объявляет, что она получила петицию с просьбой частично освободить от требований к предварительной нотификации для радиологии компьютерно-аided detection and/or diagnostic devices and computer-aided triage and notification devices. Specifically, the petition requests exemption from the pre-market notification requirements for the following generic device types when certain conditions described in the petitions are with: radiological computer-assisted diagnostic software for lesions suspicious of cancer; medical image analyzers; radiological computed aided triaage and notification software; and radiological computers-assistent detection & diagonal diagnostics software;