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Electronic Products Radiation Control - Ionizing Radiation Products

• Medical Diagnostic X-Ray Equipment
• Perfornance Standards
  • Ionizing Radiation Emitting Products
  • Radiographic
  • Fluoroscopic
  • Computed Tomography (CT)
• Reporting Guide - Annual Report
• Radiation Inuries with Fluoroscopy
• Guidance for FDA STaff - Compliance Program Guidance Manual: Field Compliance Testing of Diagnostic (Medical) X-ray Equipment
• A Guide for the Submission of an Abbreviated Radiation Safety Report on Cephalometric Devices Intended for Diagnostic Use
• Routine Compliance Testing Procedures for Diagnostic X-Ray Systems
• Resource Manual for Compliance Test Parameters of Diagnostic X-Ray Systems
• Information Disclosure by Manufacturers to Assemblers for Diagnostic X-ray Systems; Final Guidance for Industry & FDA

• Cabinet X-Ray Systems
• Frequently Asked Questions on Cabinet X-ray Systems
• Performance Standard (Title 21 CFR 1020.40)
• Reporting Guide - Radiation Safety Product
• Reporting Guide - Annual Report
• Procedures for Testing Cabinet X-Ray Systems for Compliance with the Standard

• Televisions and Video Display Monitors
• Performance Standard
• Reporting Guide
• Changes to Annual Reports
• Exclusion from Radiation Standard for Camcorder Viewfinders
• Laboratory Testing Procedures
• Sampling of Products for Laboratory Testing

• X-Ray & Particulate Products other the Medical Diagnostic or Cabinet
  (The following reporting guides are out of date. Follow the requirements of TItle 21 CFR 1002.12 and use these guides as background material to determine what information would be useful to submit.)

• Accelerators
• Industrial X-Ray Equpment
• Analytical X-Ray Equipment
• Reporting Guide - Annual Report
• NBS Handbook 111 - Radiation Safety for X-Ray Diffraction & Fluoresence Analysis Equipment

• Security and Surveillance Products
  • X Radiation