Product code

RBR: Diagnostic x-ray equipment (noncertified)

FDA product code · Not Classified

Key facts

Product code RBR
Device Diagnostic x-ray equipment (noncertified)
Device class Not Classified
GMP exempt Yes
Definition Diagnostic x-ray equipment or components manufactured before the dates specified in the applicability section in 21 cfr 1020.30(a).

At a glance

  • None 510(k) clearances
  • None De Novo grants
  • None PMA approvals
  • None HDE approvals
  • None UDI devices (GUDID)
  • None 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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