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Performance Standards for Diagnostic X-Ray Systems and Major Components

This guidance covers performance standards for medical diagnostic x-ray systems and their major components, including radiographic, fluoroscopic, and computed tomography (CT) systems. It specifically addresses new requirements for equipment manufactured on or after June 10, 2006.

  1. Review and update warning labels on control panels
  2. Implement new display requirements for fluoroscopic irradiation time and air kerma
  3. Update user documentation with required mode of operation information
  4. Verify compliance with new HVL and aluminum equivalent material requirements
  5. Implement maintenance schedules for air kerma display systems
  6. Ensure proper labeling for modified equipment
  7. Verify field limitation compliance for fluoroscopic imaging assemblies
  8. Implement and verify Last-Image-Hold functionality requirements
  9. Document any system modifications in system records
  10. Train staff on new display features and safety requirements

Key Considerations

Non-clinical testing

  • Minimum HVL requirements have been increased for x-ray systems manufactured after June 10, 2006
  • Maximum aluminum equivalent material between patient and image receptor has been increased
  • Display of AKR and cumulative air kerma values must not deviate from actual values by more than ±35%

Human Factors

  • Warning label must be legible and accessible on the control panel
  • Clear indication required for LIH (Last-Image-Hold) radiograph vs. fluoroscopic image
  • Audible signal required for every 5 minutes of fluoroscopic irradiation time

Labelling

  • New warning statement required on control panel
  • Modified equipment must bear label indicating compliance with 21 CFR 1020.32(h)(2)
  • Systems with SSD less than 45 cm must be labeled for extremity use only

Software

  • Display requirements for fluoroscopic irradiation time
  • Requirements for AKR and cumulative air kerma display updates and accuracy
  • Display requirements for Last-Image-Hold (LIH) functionality

Safety

  • New requirements for minimum source-skin distance
  • Optional filtration requirements for high-power fluoroscopic systems
  • Field limitation requirements for circular and rectangular image receptors

Other considerations

  • IEC: Standards for radioscopy terminology and definitions
  • International Commission on Radiation Units and Measurements: Kerma definition and units

Original guidance

  • Performance Standards for Diagnostic X-Ray Systems and Major Components
  • HTML / PDF
  • Issue date: 2023-02-21
  • Last changed date: 2023-02-21
  • Status: FINAL
  • Official FDA topics: Medical Devices, Radiation-Emitting Products, Radiology
  • ReguVirta summary file ID: baa32dc9df86974fd9f07d90dd043be3
This post is licensed under CC BY 4.0 by the author.