21 CFR Chapter I Subchapter H β Medical Devices β Part 872 Dental Devices From Food and Drug Administration (FDA) πΊπΈ This document is a regulation titled "21 CFR Chapter I Subchapter H β Medical Devices β Part 872 Dental 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
Pediatric Information for X-ray Imaging Device Premarket Notifications: Guidance for Industry and Food and Drug Administration Staff From Food and Drug Administration (FDA) πΊπΈ 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
21 CFR Chapter I Subchapter H β Medical Devices β Part 892 Radiology Devices From Food and Drug Administration (FDA) πΊπΈ This document is a regulation titled "21 CFR Chapter I Subchapter H β Medical Devices β 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
Performance Standard for Diagnostic X-Ray Systems and Their Major Components (21CFR 1020.30, 1020.31, 1020.32, 1020.33); Small Entity Compliance Guide From Food and Drug Administration (FDA) πΊπΈ This document is a guidance document titled "Performance Standard for Diagnostic X-Ray Systems and Their Major Components". 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
Medical X-Ray Imaging Devices Conformance with IEC Standards: Guidance for Industry and Food and Drug Administration Staff From Food and Drug Administration (FDA) πΊπΈ 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
Guidance for Industry and Food and Drug Administration Staff - Assembler's Guide to Diagnostic X-Ray Equipment From Food and Drug Administration (FDA) πΊπΈ Guidance document providing information for FDA staff and industry on diagnostic X-ray equipment assembly. 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
General X-ray Dose Data Collection From Saudi Food and Drug Authority (SFDA) πΈπ¦ Form for collecting general X-ray dose data. 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
CPG Sec. 398.300 Registration of Assemblers of Diagnostic X-Ray Systems as Device Manufacturers From Food and Drug Administration (FDA) πΊπΈ This document is a Compliance Policy Guide (CPG) titled "CPG Sec. 398.300 Registration of Assemblers of Diagnostic X-Ray Systems as Device Manufacturers". 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 6, 2021 Other (Public Domain) 0 reuses 0 favorites
CPG Sec. 398.100 Definition of General Purpose Radiographic X-Ray System - 21 CFR 1020.30(b) From Food and Drug Administration (FDA) πΊπΈ This document is a Compliance Policy Guide that defines the General Purpose Radiographic X-Ray System according to 21 CFR 1020.30(b). 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 6, 2021 Other (Public Domain) 0 reuses 0 favorites
CPG Sec. 398.200 Hazardous Diagnostic X-ray Systems From Food and Drug Administration (FDA) πΊπΈ This document is titled "CPG Sec. 398.200 Hazardous Diagnostic X-ray Systems" and is a Compliance Policy Guide (CPG). 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 3, 2021 Other (Public Domain) 0 reuses 0 favorites
Clarification of Radiation Control Regulations For Manufacturers of Diagnostic X-Ray Equipment: Draft Guidance for Industry and Food and Drug Administration Staff From Food and Drug Administration (FDA) πΊπΈ This document is a draft guidance for manufacturers of diagnostic X-ray equipment, providing clarification on radiation control regulations. Topics covered include export, import, and labeling. 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 26, 2021 Other (Public Domain) 0 reuses 0 favorites
Radiation Safety Considerations for X-Ray Equipment Designed for Hand-Held Use From Food and Drug Administration (FDA) πΊπΈ This document is a guidance on radiation safety for hand-held X-ray equipment, focusing on postmarket considerations. 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 24, 2020 Other (Public Domain) 0 reuses 0 favorites
Compliance Guide for Cabinet X-Ray Systems From Food and Drug Administration (FDA) πΊπΈ A compliance guide providing guidance for Cabinet X-Ray Systems. Metadata quality: Metadata quality: Data description empty 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: 55.55555555555556/100 Updated on March 24, 2020 Other (Public Domain) 0 reuses 0 favorites
Information Disclosure by Manufacturers to Assemblers for Diagnostic X-ray Systems - Guidance for Industry and FDA Staff From Food and Drug Administration (FDA) πΊπΈ This document is a guidance for industry and FDA staff on information disclosure by manufacturers to assemblers for diagnostic X-ray systems. 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 19, 2020 Other (Public Domain) 0 reuses 0 favorites
Manufacturers/Assemblers of Diagnostic X-ray Systems: Enforcement Policy for Positive-Beam Limitation (PBL) Requirements in 21 CFR 1020.31(g) : From Food and Drug Administration (FDA) πΊπΈ This is a guidance document for manufacturers and assemblers of diagnostic X-ray systems regarding the enforcement policy for positive-beam limitation 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 March 17, 2020 Other (Public Domain) 0 reuses 0 favorites
Guidance for the Submission of Cabinet X-Ray System Reports Pursuant to 21-CFR 1020.40 From Food and Drug Administration (FDA) πΊπΈ A guidance document providing instructions for submitting reports on Cabinet X-Ray Systems in accordance with 21-CFR 1020.40. 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 16, 2020 Other (Public Domain) 0 reuses 0 favorites
Clarification of Radiation Control Regulations for Diagnostic X-Ray Equipment (Part 3) From Food and Drug Administration (FDA) πΊπΈ Guidance document providing clarification on radiation control regulations for diagnostic X-ray equipment (Part 3). 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 2, 2020 Other (Public Domain) 0 reuses 0 favorites
Clarification of Radiation Control Regulations for Diagnostic X-Ray Equipment (Part 2) From Food and Drug Administration (FDA) πΊπΈ A memorandum providing clarification on radiation control regulations for diagnostic X-ray equipment. 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 2, 2020 Other (Public Domain) 0 reuses 0 favorites
Clarification of Radiation Control Regulations for Diagnostic X-Ray Equipment (Part 1 ) From Food and Drug Administration (FDA) πΊπΈ Guidance document providing clarification on radiation control regulations for diagnostic X-ray equipment (Part 1). 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 2, 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) πΊπΈ 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