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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.

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By ReguVirta
3 min read

What You Need to Know? 👇

What are the labeling requirements for X-ray component model numbers under 21 CFR 1020.30(e)?

The word “model” or “type” must appear as part of the manufacturer’s identification. Model designations must be unique to each certified component and cannot describe assemblages of components unless specifically approved by CDRH.

Where should identification labels be placed on X-ray components for FDA compliance?

Labels must be readily accessible without unbolting, unlocking, or relocating the X-ray system. They should be on the outside of equipment, not on sides normally placed against walls, and visible during routine inspections.

What constitutes “legible and accessible to view” for X-ray component identification?

The label must be readable without requiring inspectors to crawl, use mirrors, or remove system parts. If behind doors or panels, clear wording must indicate the label’s location on the accessible surface.

Are part numbers or catalog numbers acceptable as model designations for X-ray components?

No, part numbers, style numbers, type numbers, and catalog numbers do not meet the intent of Section 1020.30(e). The specific word “model” or “type” must be clearly indicated on the component.

What serial number requirements apply to certified X-ray components?

The words “serial number” or reasonable abbreviation must appear as part of the serial identification. Both model and serial numbers must be permanently inscribed or affixed to each certified component.

When must manufacturers report changes to X-ray component model designations?

Changes in model designations must be reported to CDRH through a supplement to their applicable initial reports. This ensures proper tracking and compliance with certification requirements for modified components.

What You Need to Do 👇

  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

  • Changes in model designations must be reported to CDRH through supplements to initial reports
  • Model designations cannot be used to describe assemblages of components unless specifically approved by CDRH

Relevant Guidances đź”—

Related references and norms đź“‚

  • 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 ID: f74db46aaf26d2262a523e17b0c8ded4
FDA guidance, Final
Medical Devices Radiation-Emitting Products Investigation & Enforcement
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