Description
The Code of Federal Regulations, Title 21, Section 1020.30(e) requires that manufacturers of components of diagnostic x-ray equipment subject to the Performance Standard shall: (1) permanently inscribe or affix thereon the model number and serial number of the component so as to be: (2) legible and accessible to view.
Scope & Applicability
Product Classes
1Equipment subject to the Performance Standard for ionizing radiation.
Stakeholders
2responsibilities provided in FDA's guidance regarding installation; Personnel who install equipment and must follow manufacturer instructions.; Reports installation of diagnostic x-ray systems; Defined as any person engaged in the business of assembling, replacing, or installing components into a diagnostic x-ray system.; Person who installs, adjusts, and tests equipment
Entity required to conduct postmarket surveillance; entity responsible for submitting postmarket surveillance plans; Entity holding the approved PMA, HDE, or cleared 510(k); The entity responsible for conducting postmarket surveillance and submitting reports.; Entity that can use the checklist as a reference for submissions.
Regulatory Context
Attributes
1The required state for identification labels on x-ray components.
Related CFR Sections (3)
- 21CFR1010.3§ 1010.3 Identification.
(a) Every manufacturer of an electronic product to which a standard under this subchapter is applicable shall set forth the information specified in paragraphs (a)(1) and (2) of this section. This information shall be provided in the form of a tag or label permanently affixed or inscribed on such prRead full regulation →
- 21CFR1010.2§ 1010.2 Certification.
(a) Every manufacturer of an electronic product for which an applicable standard is in effect under this subchapter shall furnish to the dealer or distributor, at the time of delivery of such product, the certification that such product conforms to all applicable standards under this subchapter.Read full regulation →
- 21CFR1020.30§ 1020.30 Diagnostic x-ray systems and their major components.
(a) Applicability.Read full regulation →
See Also (8)
- Quality Control Practices for Compliance with the Federal Laser Performance Standard (Status: Final)
- Manufacture and Certification of Laser Kits (Laser Notice 13) (Status: Final)
- Identification Labels for Certain Class I Laser Products (Laser Notice 48) (Status: Final)
- Clarification of Radiation Control Regulations for Diagnostic X-Ray Equipment (Part 3) (Status: Final)
- Procedures for Laboratory Testing of Microwave Ovens (Status: Final)
- Quality Control Guide for Sunlamp Products (FDA 88-8234) (Status: Final)
- Labeling - Regulatory Requirements for Medical Devices (FDA 89-4203) (Status: Final)
- Compliance Guide for Laser Products (FDA 86-8260) (Status: Final)