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.
What You Need to Know? 👇
What are the key changes in the 2006 FDA performance standards for diagnostic X-ray systems?
The 2006 amendments increased minimum HVL requirements, added coverage for electrically powered image receptors and fluoroscopic air kerma display devices, introduced new definitions like “air kerma” and “C-arm fluoroscope,” and established requirements for displaying air kerma rates and cumulative air kerma values.
Which medical devices are covered under 21 CFR 1020.30-1020.33 performance standards?
The standards apply to all medical diagnostic X-ray systems and major components, including radiographic, fluoroscopic, and computed tomography (CT) systems. Coverage includes X-ray tube assemblies, image receptors, control panels, and fluoroscopic air kerma display devices manufactured after specified dates.
What are the new air kerma display requirements for fluoroscopic equipment?
Fluoroscopic equipment manufactured after June 10, 2006 must display air kerma rate (AKR) in mGy/min continuously during activation and cumulative air kerma in mGy within 5 seconds of exposure termination. Displays must be accurate within ±35% and clearly distinguishable from each other.
What documentation is required when modifying certified diagnostic X-ray systems?
Owners modifying diagnostic X-ray systems must record the modification date and details in system records, ensuring modifications don’t cause non-compliance with applicable CFR sections. The modification must not result in failure to meet performance standards under sections 1020.31, 1020.32, or 1020.33.
What are the minimum source-skin distance requirements for C-arm fluoroscopic systems?
C-arm fluoroscopic systems manufactured after June 10, 2006 with maximum source-image receptor distance less than 45 cm must limit source-skin distance to at least 19 cm and be labeled for extremity use only. Special surgical applications may operate at shorter distances but never less than 10 cm.
What additional filtration requirements apply to high-power fluoroscopic systems?
Fluoroscopic systems manufactured after June 10, 2006 with continuous output ≥1 kilowatt and anode heat storage ≥1 million heat units must provide optional additional X-ray filtration beyond HVL requirements. Selection must be user-controlled or automatic, with clear indication of active filtration combination.
What You Need to Do 👇
Recommended Actions
- Review and update warning labels on control panels
- Implement new display requirements for fluoroscopic irradiation time and air kerma
- Update user documentation with required mode of operation information
- Verify compliance with new HVL and aluminum equivalent material requirements
- Implement maintenance schedules for air kerma display systems
- Ensure proper labeling for modified equipment
- Verify field limitation compliance for fluoroscopic imaging assemblies
- Implement and verify Last-Image-Hold functionality requirements
- Document any system modifications in system records
- 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
- Documentation requirements for system modifications by owners
- Maintenance schedule requirements for air kerma display systems
- Detailed mode of operation information must be provided in user manual
Relevant Guidances 🔗
- X-Ray Equipment Performance Standards and Radiation Safety Requirements
- Assembly and Installation Requirements for Diagnostic X-ray Equipment and Components
- Harmonization of Performance Standards for Diagnostic X-Ray Imaging Systems and Components with IEC Standards
- Cybersecurity for Networked Medical Devices with Off-The-Shelf Software
- Content of Premarket Submissions for Device Software Functions
- Off-The-Shelf Software in Medical Devices: Documentation Requirements for Premarket Submissions
Related references and norms 📂
- IEC: Standards for radioscopy terminology and definitions
- International Commission on Radiation Units and Measurements: Kerma definition and units