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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.

  1. Determine if clinical testing is needed based on device modifications
  2. Prepare comprehensive non-clinical testing documentation including:
    • Physical and operational characteristics
    • Performance measurements (DQE, MTF, etc.)
    • Test results with sample images
  3. Develop complete labeling package including:
    • Indications for use
    • User manuals and instructions
    • Training materials
    • Performance documentation
  4. Establish Quality Assurance Program with:
    • Monitoring procedures
    • Acceptance criteria
    • Record keeping system
    • Training materials
  5. Ensure compliance with radiation safety standards
  6. Consider pre-submission consultation with FDA for feedback on testing requirements
  7. 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

  • 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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