CFR section

21 CFR 1020.30(e): Diagnostic x-ray systems and their major components

PART 1020-PERFORMANCE STANDARDS FOR IONIZING RADIATION EMITTING PRODUCTS

Key facts

Citation 21 CFR 1020.30(e)
Section Diagnostic x-ray systems and their major components
Part PART 1020-PERFORMANCE STANDARDS FOR IONIZING RADIATION EMITTING PRODUCTS
Subchapter 21 CFR J Radiological
Product types cited Devices
Regulation text (excerpt) (e) Identification of x-ray components. In addition to the identification requirements specified in § 1010.3 of this chapter, manufacturers of components subject to this section and §§ 1020.31, 1020.32, and 1020.33, except high-voltage generators contained within tube housings and beam-limiting devices that are integral parts of tube housings, shall permanently inscribe or affix thereon the model number and serial number of the product so that they are legible and accessible to view. The word…

At a glance

  • 1–9 Inspections citing this section
  • None Warning letters citing this section

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About CFR sections cited by the FDA

Title 21 of the Code of Federal Regulations contains the FDA's regulations, including current good manufacturing practice and quality system requirements that inspections cite.

Source: U.S. Code of Federal Regulations (eCFR); citation statistics from FDA inspection and warning-letter data

Browse all CFR sections cited by the FDA