X-ray Field Size Control Requirements for Fluoroscopic and Spot-Film Systems
This guidance clarifies requirements for automatic adjustment of X-ray field size in fluoroscopic/spot-film systems, specifically addressing situations where the X-ray field size is smaller than the selected spot-film size, as per 21 CFR 1020.31(g)(1).
Recommended Actions
- Review current system design to ensure compliance with field size adjustment requirements
- Implement one of the three acceptable design options for field size control
- For dual-purpose X-ray tubes, ensure compliance with both PBL and spot-film device requirements
- Verify that system design prioritizes minimizing patient radiation exposure
- Document system controls and operational modes in technical documentation
- Ensure user interface clearly indicates current operational mode and control options
- Validate that fluoroscopist maintains control over field size selection at all times
Key Considerations
Human Factors
- System must allow fluoroscopist to maintain control over X-ray field size
- Manual controls or mode selection must be easily accessible to the operator
Safety
- System must prevent automatic enlargement of X-ray field size when current field is smaller than selected spot-film size
- Design must minimize unnecessary radiation exposure to patients
- For systems using same X-ray tube for spot film and other radiographic procedures, PBL requirements must be met
Other considerations
- Acceptable system designs must include one of the following:
- Radiation Safety Requirements for Diagnostic X-Ray Systems and Components
- Radiation Control Requirements and Interpretations for Diagnostic X-ray Equipment
- X-Ray Equipment Performance Standards and Radiation Safety Requirements
- Harmonization of Performance Standards for Diagnostic X-Ray Imaging Systems and Components with IEC Standards
Related references and norms
- 21 CFR 1020.31: Performance standards for radiographic equipment
Original guidance
- X-ray Field Size Control Requirements for Fluoroscopic and Spot-Film Systems
- HTML
- Issue date: 1980-09-30
- Last changed date: 2018-12-01
- Status: FINAL
- Official FDA topics: Medical Devices, Radiation-Emitting Products, Radiology, Investigation & Enforcement
- ReguVirta summary file ID: d5dc2c1b008d4922d8053416eea18d54
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