21 CFR Chapter I Subchapter H โ Medical Devices โ Part 876 Gastroenterology-Urology Devices From Food and Drug Administration (FDA) ๐บ๐ธ Regulation on Gastroenterology-Urology Devices under 21 CFR Chapter I Subchapter H - Medical Devices, Part 876. 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 2 days ago Other (Public Domain) 0 reuses 0 favorites
21 CFR Chapter I Subchapter H โ Medical Devices โ Part 864 Hematology and Pathology 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 864 Hematology and Pathology 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 2 weeks ago Other (Public Domain) 0 reuses 0 favorites
21 CFR Chapter I Subchapter H โ Medical Devices โ Part 878 General and Plastic Surgery 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 878 General and Plastic Surgery 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 4, 2024 Other (Public Domain) 0 reuses 0 favorites
Use of Whole Slide Imaging in Nonclinical Toxicology Studies: Questions and Answers: Guidance for Industry From Food and Drug Administration (FDA) ๐บ๐ธ A guidance document titled "Use of Whole Slide Imaging in Nonclinical Toxicology Studies: Questions and Answers: Guidance for Industry". 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 April 8, 2024 Other (Public Domain) 0 reuses 0 favorites
Pediatric Information for X-ray Imaging Device Premarket Notifications: Guidance for Industry and Food and Drug Administration Staff From Food and Drug Administration (FDA) ๐บ๐ธ A guidance document for industry and FDA staff on premarket notifications for pediatric X-ray imaging devices. 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 April 8, 2024 Other (Public Domain) 0 reuses 0 favorites
Guidance on SFDA Requirements for Quality Assurance Programs for Radiation Emitting and Imaging Devices (MDS-G15) From Saudi Food and Drug Authority (SFDA) ๐ธ๐ฆ Guidance on quality assurance programs for radiation emitting and imaging devices as per SFDA requirements. 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 on September 28, 2023 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
Medical X-Ray Imaging Devices Conformance with IEC Standards: Guidance for Industry and Food and Drug Administration Staff From Food and Drug Administration (FDA) ๐บ๐ธ This document provides guidance for the industry and FDA staff on the conformance of medical X-ray imaging devices with IEC standards. 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 February 21, 2023 Other (Public Domain) 0 reuses 0 favorites
High-field magnetic resonance imaging (MRI) equipment From Ministry of Health (Italy) (MDS) ๐ฎ๐น This document discusses high-field MRI equipment, which is a special type of medical device used for imaging. 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 12, 2023 Creative Commons Attribution 3.0 0 reuses 0 favorites
Technical Performance Assessment of Quantitative Imaging in Radiological Device Premarket Submissions: Guidance for Industry and Food and Drug Administration Staff From Food and Drug Administration (FDA) ๐บ๐ธ This document is a guidance document titled "Technical Performance Assessment of Quantitative Imaging in Radiological Device Premarket Submissions". It focuses on premarket topics and is intended for 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 filled Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 66.66666666666666/100 Updated on June 15, 2022 Other (Public Domain) 0 reuses 0 favorites
Requirements for the Import and Clearance of Medical Imaging Materials and Particle Accelerators Used in Radioisotopes Formation for Medical Applications From Saudi Food and Drug Authority (SFDA) ๐ธ๐ฆ Guidance on the import and clearance process for medical imaging materials and particle accelerators used in radioisotope formation. 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 on March 27, 2022 Other (Public Domain) 0 reuses 0 favorites
New Contrast Imaging Indication Considerations for Devices and Approved Drug and Biological Products: Guidance for Industry From Food and Drug Administration (FDA) ๐บ๐ธ Guidance for Industry on new contrast imaging indication considerations for combination products and approved drug and biological products. 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 May 14, 2020 Other (Public Domain) 0 reuses 0 favorites
Guidance for the Submission of 510(k)s for Solid State X-ray Imaging Devices: Guidance for Industry and Food and Drug Administration Staff From Food and Drug Administration (FDA) ๐บ๐ธ Guidance for the Submission of 510(k)s for Solid State X-ray Imaging Devices: Guidance for Industry and FDA Staff. Covers premarket requirements. 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 May 13, 2019 Other (Public Domain) 0 reuses 0 favorites
Technical Performance Assessment of Digital Pathology Whole Slide Imaging Devices : Guidance for Industry and Food and Drug Administration Staff From Food and Drug Administration (FDA) ๐บ๐ธ This document is a guidance document titled "Technical Performance Assessment of Digital Pathology Whole Slide Imaging Devices". It focuses on labeling and premarket topics. 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 March 28, 2019 Other (Public Domain) 0 reuses 0 favorites
MD Application Imaging Products Importation and Clearance From Saudi Food and Drug Authority (SFDA) ๐ธ๐ฆ MD Application Imaging Products Importation and Clearance form. 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 March 2, 2019 Other (Public Domain) 0 reuses 0 favorites
Medical Devices; General and Plastic Surgery Devices; Classification of the Wound Autofluorescence Imaging Device From Food and Drug Administration (FDA) ๐บ๐ธ Document number 2018-22837. The Food and Drug Administration (FDA or we) is classifying the wound autofluorescence imaging device into class I. We are taking this action because we have determined that classifying the device into class I will provide a reasonable assurance of safety andโฆ 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 October 19, 2018 Other (Public Domain) 0 reuses 0 favorites
Medical Devices; Hematology and Pathology Devices; Classification of the Whole Slide Imaging System From Food and Drug Administration (FDA) ๐บ๐ธ Document number 2017-28262. The Food and Drug Administration (FDA or we) is classifying the whole slide imaging system 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 whole slideโฆ 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 2, 2018 Other (Public Domain) 0 reuses 0 favorites
Medical Devices; Gastroenterology-Urology Devices; Classification of the Colon Capsule Imaging System From Food and Drug Administration (FDA) ๐บ๐ธ Document number 2014-11173. The Food and Drug Administration (FDA) is classifying the colon capsule imaging system into class II (special controls). The special controls that will apply to the device are identified in this order and will be part of the codified language for the colon capsuleโฆ 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 16, 2014 Other (Public Domain) 0 reuses 0 favorites
Notice on the definition of the classification of medical imaging diagnostic systems and other products From National Medical Products Administration (NMPA) ๐จ๐ณ FGWJ-2009-10064 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 February 13, 2009 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