21 CFR Chapter I Subchapter H – Medical Devices – Part 892 Radiology Devices From Food and Drug Administration (FDA) 🇺🇸 This document is a regulation titled "21 CFR Chapter I Subchapter H – Medical Devices – Part 892 Radiology Devices". Metadata quality: Metadata quality: Data description filled Files documented License filled Update frequency not followed File formats are open Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 77.77777777777779/100 Updated on June 7, 2023 Other (Public Domain) 0 reuses 0 favorites
Display Devices for Diagnostic Radiology: Guidance for Industry and Food and Drug Administration Staff From Food and Drug Administration (FDA) 🇺🇸 This document is a guidance for labeling and premarket requirements for display devices used in diagnostic radiology. Metadata quality: Metadata quality: Data description filled Files documentation missing License filled Update frequency not followed File formats are closed Temporal coverage filled Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 66.66666666666666/100 Updated on September 27, 2022 Other (Public Domain) 0 reuses 0 favorites
Computer-Assisted Detection Devices Applied to Radiology Images and Radiology Device Data - Premarket Notification [510(k)] Submissions: Guidance for Industry and Food and Drug Administration Staff From Food and Drug Administration (FDA) 🇺🇸 A guidance document for industry and FDA staff on premarket notification submissions for computer-assisted detection devices in radiology. Metadata quality: Metadata quality: Data description filled Files documentation missing License filled Update frequency not followed File formats are closed Temporal coverage filled Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 66.66666666666666/100 Updated on September 27, 2022 Other (Public Domain) 0 reuses 0 favorites
Clinical Performance Assessment: Considerations for Computer-Assisted Detection Devices Applied to Radiology Images and Radiology Device Data in Premarket Notification (510(k)) Submissions: Guidance for Industry and FDA Staff From Food and Drug Administration (FDA) 🇺🇸 This document provides guidance for industry and FDA staff on clinical performance assessment of computer-assisted detection devices in radiology. Metadata quality: Metadata quality: Data description filled Files documentation missing License filled Update frequency not followed File formats are closed Temporal coverage filled Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 66.66666666666666/100 Updated on September 27, 2022 Other (Public Domain) 0 reuses 0 favorites
Radiology Devices; Reclassification of Medical Image Analyzers From Food and Drug Administration (FDA) 🇺🇸 Document number 2020-00494. The Food and Drug Administration (FDA or the Agency) is issuing a final order to reclassify medical image analyzers applied to mammography breast cancer, ultrasound breast lesions, radiograph lung nodules, and radiograph dental caries detection, postamendments class III… Metadata quality: Metadata quality: Data description filled Files documentation missing License filled Update frequency not followed File formats are open Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 66.66666666666666/100 Updated on January 22, 2020 Other (Public Domain) 0 reuses 0 favorites
Medical Devices; Radiology Devices; Classification of the Radiological Computer-Assisted Diagnostic Software for Lesions Suspicious for Cancer From Food and Drug Administration (FDA) 🇺🇸 Document number 2020-00497. The Food and Drug Administration (FDA or we) is classifying the radiological computer-assisted diagnostic (CADx) software for lesions suspicious for cancer into class II (special controls). The special controls that apply to the device type are identified in this order… Metadata quality: Metadata quality: Data description filled Files documentation missing License filled Update frequency not followed File formats are open Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 66.66666666666666/100 Updated on January 22, 2020 Other (Public Domain) 0 reuses 0 favorites
Medical Devices; Radiology Devices; Classification of the Radiological Computer Aided Triage and Notification Software From Food and Drug Administration (FDA) 🇺🇸 Document number 2020-00496. The Food and Drug Administration (FDA or we) is classifying the radiological computer aided triage and notification software into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the… Metadata quality: Metadata quality: Data description filled Files documentation missing License filled Update frequency not followed File formats are open Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 66.66666666666666/100 Updated on January 22, 2020 Other (Public Domain) 0 reuses 0 favorites
Radiology Devices; Reclassification of Medical Image Analyzers From Food and Drug Administration (FDA) 🇺🇸 Document number 2018-11880. The Food and Drug Administration (FDA or the Agency) is issuing this proposed order to reclassify medical image analyzers applied to mammography breast cancer, ultrasound breast lesions, radiograph lung nodules, and radiograph dental caries detection as postamendments… Metadata quality: Metadata quality: Data description filled Files documentation missing License filled Update frequency not followed File formats are open Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 66.66666666666666/100 Updated on June 4, 2018 Other (Public Domain) 0 reuses 0 favorites
Medical Devices; Radiology Devices; Classification of the Absorbable Perirectal Spacer From Food and Drug Administration (FDA) 🇺🇸 Document number 2018-00051. The Food and Drug Administration (FDA or we) is classifying the absorbable perirectal spacer into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the absorbable… Metadata quality: Metadata quality: Data description filled Files documentation missing License filled Update frequency not followed File formats are open Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 66.66666666666666/100 Updated on January 5, 2018 Other (Public Domain) 0 reuses 0 favorites
Medical Devices; Radiology Devices; Classification of the Rectal Balloon for Prostate Immobilization From Food and Drug Administration (FDA) 🇺🇸 Document number 2017-27856. The Food and Drug Administration (FDA or we) is classifying the rectal balloon for prostate immobilization into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the… Metadata quality: Metadata quality: Data description filled Files documentation missing License filled Update frequency not followed File formats are open Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 66.66666666666666/100 Updated on December 27, 2017 Other (Public Domain) 0 reuses 0 favorites
Medical Devices; Radiology Devices; Reclassification of Full-Field Digital Mammography System From Food and Drug Administration (FDA) 🇺🇸 Document number 2010-28007. The Food and Drug Administration (FDA) is announcing the reclassification of the full-field digital mammography (FFDM) system from class III (premarket approval) to class II (special controls). The device type is intended to produce planar digital x-ray images of the… Metadata quality: Metadata quality: Data description filled Files documentation missing License filled Update frequency not followed File formats are open Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 66.66666666666666/100 Updated on November 5, 2010 Other (Public Domain) 0 reuses 0 favorites
Medical Devices; Radiology Devices; Reclassification of Bone Sonometers From Food and Drug Administration (FDA) 🇺🇸 Document number E8-16354. The Food and Drug Administration (FDA) is issuing a final rule to reclassify bone sonometer devices from class III into class II, subject to special controls. FDA is taking this action on its own initiative after reviewing recent scientific and technological studies… Metadata quality: Metadata quality: Data description filled Files documentation missing License filled Update frequency not followed File formats are open Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 66.66666666666666/100 Updated on July 17, 2008 Other (Public Domain) 0 reuses 0 favorites
Medical Devices; Radiology Devices; Reclassification of Full Field Digital Mammography System From Food and Drug Administration (FDA) 🇺🇸 Document number E8-12120. The Food and Drug Administration (FDA) is proposing to reclassify the full field digital mammography (FFDM) system from class III (premarket approval) to class II (special controls). The device type is intended to produce full field digital x-ray images of the breast.… Metadata quality: Metadata quality: Data description filled Files documentation missing License filled Update frequency not followed File formats are open Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 66.66666666666666/100 Updated on May 30, 2008 Other (Public Domain) 0 reuses 0 favorites