Solid State X-ray Imaging Devices for Medical Diagnostic Use
This guidance applies to Solid State X-ray Imagers (SSXI) that convert x-ray patterns into electrical signals for medical diagnosis. It covers devices intended to replace conventional x-ray film/screen systems and image intensifier-based fluoroscopic systems, excluding devices for mammography.
Recommended Actions
- Determine if clinical testing is needed based on device modifications
- Prepare comprehensive non-clinical testing documentation including:
- Physical and operational characteristics
- Performance measurements (DQE, MTF, etc.)
- Test results with sample images
- Develop complete labeling package including:
- Indications for use
- User manuals and instructions
- Training materials
- Performance documentation
- Establish Quality Assurance Program with:
- Monitoring procedures
- Acceptance criteria
- Record keeping system
- Training materials
- Ensure compliance with radiation safety standards
- Consider pre-submission consultation with FDA for feedback on testing requirements
- Prepare 510(k) submission incorporating all required elements from guidance
Key Considerations
Clinical testing
- Concurrence study with 30+ clinical image pairs showing equivalent diagnostic capability to predicate device
- Qualified expert evaluation of representative clinical images for intended anatomical regions
- Clinical images must be accompanied by acquisition parameters and dose information
- Clinical testing may not be needed for certain modifications (dimension changes, pixel size changes, wireless functionality changes)
Non-clinical testing
- Physical characteristics (dimensions, sensor elements, structure, interconnections)
- Operational functions (exposure methods, x-ray absorption, energy conversion, readout mechanisms)
- Functional characteristics (DQE, MTF, dynamic range, lag effects, defect handling)
- Exposure characteristics (dose requirements, stability, uniformity, frame rates)
- Test results with sample images and measurements
Labelling
- Indications for use
- Promotional materials
- Instructions for installation, checkout and use
- Training materials
- Documentation of imaging performance characteristics
Safety
- Ready signal indication for x-ray input acceptance
- Compliance with radiation safety standards
- Safety features documentation
Other considerations
- Quality Assurance Program requirements
- Parameter monitoring procedures
- Quality criteria and acceptance limits
- Manufacturer records maintenance
- QA training materials
Relevant Guidances
- Technical Performance Assessment and Premarket Requirements for Digital Diagnostic Radiology Display Devices
- Harmonization of Performance Standards for Diagnostic X-Ray Imaging Systems and Components with IEC Standards
- Performance Standard Requirements for Fluoroscopic X-Ray Systems: Timing, Safety Features and Display Requirements
- Pediatric X-Ray Imaging Device Premarket Submissions: Design, Testing, and Labeling Considerations
Related references and norms
- 21 CFR 1020.30: Diagnostic x-ray systems and their major components
- 21 CFR 1020.31: Radiographic equipment
- 21 CFR 1020.32: Fluoroscopic equipment
- 21 CFR Parts 50 and 56: Protection of Human Subjects and Institutional Review Boards
Original guidance
- Solid State X-ray Imaging Devices for Medical Diagnostic Use
- HTML / PDF
- Issue date: 2016-09-01
- Last changed date: 2019-05-13
- Status: FINAL
- Official FDA topics: Radiation-Emitting Products, Medical Devices, 510(k), Premarket, Radiological Health, Radiology
- ReguVirta summary file ID: 7737a93f9d6ce1520d770831cc912274
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