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Model and Serial Number Labeling Requirements for X-Ray System Components

This guidance clarifies the requirements for certification and identification labeling of X-ray components under 21 CFR 1020.30(e), specifically addressing how manufacturers should properly label model and serial numbers on diagnostic X-ray equipment components.

  1. Review current labeling practices to ensure compliance with model and serial number requirements
  2. Verify that all component labels are readily accessible after installation
  3. Implement clear marking system for components not visible from outside
  4. Establish process for reporting model designation changes to CDRH
  5. Update labeling procedures to ensure model designations are unique to individual components
  6. Train assembly teams on proper label placement requirements
  7. Create documentation system for tracking model and serial number assignments
  8. Implement quality control checks for label accessibility during installation

Key Considerations

Labelling

  • The word “model” or “type” must appear as part of the manufacturer’s identification
  • Words “serial number” (or reasonable abbreviation) must be clearly indicated
  • Labels must be readily accessible without unbolting, unlocking, or relocating the X-ray system
  • Labels should be on the outside of equipment, not on sides normally against walls
  • For components not visible from outside (e.g., under-table tube housing), indication of label location must be provided on accessible panels/doors
  • Model designation must describe only one certified component

Other considerations

  • 21 CFR 1020.30(e): Performance Standards for Ionizing Radiation Emitting Products
  • 21 CFR 1010.2: Certification
  • 21 CFR 1010.3: Identification

Original guidance

  • Model and Serial Number Labeling Requirements for X-Ray System Components
  • HTML
  • Issue date: 1995-02-28
  • Last changed date: 2018-12-01
  • Status: FINAL
  • Official FDA topics: Medical Devices, Radiation-Emitting Products, Investigation & Enforcement
  • ReguVirta summary file ID: f74db46aaf26d2262a523e17b0c8ded4
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