Appeal Options Available to Mammography Facilities Concerning Adverse Accreditation Decisions, Suspension/Revocation of Certificates, or Patient and Referring Provider Notification Orders: Guidance for Mammography Facilities and Food and Drug Administration Staff From Food and Drug Administration (FDA) ๐บ๐ธ Guidance document outlining appeal options for mammography facilities regarding adverse accreditation decisions, certificate suspension/revocation, and notification orders. Administrative/procedural focus. Metadata quality: Metadata quality: Data description filled Files documentation missing License filled Update frequency not followed File formats are closed Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 55.55555555555556/100 Updated 1 week ago Other (Public Domain) 0 reuses 0 favorites
Mammography Quality Standards Act and Regulation Amendments: Small Entity Compliance Guide: Guidance for Industry and Food and Drug Administration Staff From Food and Drug Administration (FDA) ๐บ๐ธ A guidance document for small entities on complying with amendments to the Mammography Quality Standards Act and Regulations, aimed at industry and FDA staff. Metadata quality: Metadata quality: Data description filled Files documentation missing License filled Update frequency not followed File formats are closed Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 55.55555555555556/100 Updated 1 month ago Other (Public Domain) 0 reuses 0 favorites
21 CFR Chapter I Subchapter H โ Medical Devices โ Part 892 Radiology Devices From Food and Drug Administration (FDA) ๐บ๐ธ This document is a regulation titled "21 CFR Chapter I Subchapter H โ Medical Devices โ 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
Mammography Dose Data Collection Sheet From Saudi Food and Drug Authority (SFDA) ๐ธ๐ฆ Mammography Dose Data Collection Sheet form used for collecting data related to mammography doses. Metadata quality: Metadata quality: Data description empty Files documentation missing License filled Update frequency not followed File formats are closed Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 44.44444444444444/100 Updated on October 12, 2022 Other (Public Domain) 0 reuses 0 favorites
Radiology Devices; Reclassification of Medical Image Analyzers From Food and Drug Administration (FDA) ๐บ๐ธ 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 IIIโฆ 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) ๐บ๐ธ 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 postamendmentsโฆ 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
Food and Drug Administration General Office on mammography stereo positioning device and other 153 products classification definition notice From National Medical Products Administration (NMPA) ๐จ๐ณ FGWJ-2015-10100 Metadata quality: Metadata quality: Data description empty 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: 55.55555555555556/100 Updated on March 31, 2015 Other (Public Domain) 0 reuses 0 favorites
Medical Devices; Radiology Devices; Reclassification of Full-Field Digital Mammography System From Food and Drug Administration (FDA) ๐บ๐ธ 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 theโฆ 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 Full Field Digital Mammography System From Food and Drug Administration (FDA) ๐บ๐ธ 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.โฆ 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
On the release of YY / T 0480-2004 "diagnostic X-ray imaging equipment general and mammography anti-scattering filter grids characteristics" medical device industry standard No. 1 change order notice From National Medical Products Administration (NMPA) ๐จ๐ณ FGWJ-2005-10146 Metadata quality: Metadata quality: Data description empty 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: 55.55555555555556/100 Updated on August 15, 2005 Other (Public Domain) 0 reuses 0 favorites