Product code

RCB: X-ray controls - radiographic

FDA product code · Not Classified

Key facts

Product code RCB
Device X-ray controls - radiographic
Device class Not Classified
GMP exempt No
Definition A device which controls input power to the x-ray high-voltage generator and/or the x-ray tube. It includes equipment such as timers, phototimers, automatic brightness stabilizers, and similar devices which control the technique factors of an x-ray exposure for generating and recordingan x-ray pattern for the purpose of providing the user with an image(s) after termination of the exposure.

At a glance

  • None 510(k) clearances
  • None De Novo grants
  • None PMA approvals
  • None HDE approvals
  • None UDI devices (GUDID)
  • 10–99 MAUDE adverse event reports
  • None Recalled products (Z-numbers)

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

About FDA device product codes

FDA product codes classify medical devices by type and intended use; each code maps to a device class, a classification regulation and a review panel.

Source: U.S. Food and Drug Administration (FDA), Product Classification database

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