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.
Recommended Actions
- Review current labeling practices to ensure compliance with model and serial number requirements
- Verify that all component labels are readily accessible after installation
- Implement clear marking system for components not visible from outside
- Establish process for reporting model designation changes to CDRH
- Update labeling procedures to ensure model designations are unique to individual components
- Train assembly teams on proper label placement requirements
- Create documentation system for tracking model and serial number assignments
- 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
- X-Ray Equipment Performance Standards and Radiation Safety Requirements
- Assembly and Installation Requirements for Diagnostic X-ray Equipment and Components
- Assembly, Installation, Adjustment and Testing Information Requirements for Diagnostic X-Ray Systems
- Harmonization of Performance Standards for Diagnostic X-Ray Imaging Systems and Components with IEC Standards
Related references and norms
- 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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