Scope & Applicability
Product Classes
1Diagnostic x-ray systems
considered to be both medical devices and electronic products
Stakeholders
1Assembler
Entity responsible for installing and testing diagnostic x-ray systems.; Person engaged in assembling, replacing, or installing components into a diagnostic x-ray system.; Person or entity responsible for installing and testing x-ray components.; Person or entity responsible for installing x-ray components; Individual or firm responsible for installing and reporting x-ray equipment
Related CFR Sections (1)
See Also (3)
- Clarification of Radiation Control Regulations for Diagnostic X-Ray Equipment (Part 3) (Status: Final)
- Guidance for Industry and Food and Drug Administration Staff - Assembler's Guide to Diagnostic X-Ray Equipment (Status: Final)
- Clarification of Radiation Control Regulations For Manufacturers of Diagnostic X-Ray Equipment: Guidance for Industry and Food and Drug Administration Staff (Status: Final)