Recognized Consensus Standards: Medical Devices

Part B: Supplementary Information Sheet (SIS)

FR Recognition List Number

038

Date of Entry 01/27/2015 

FR Recognition Number

12-230

Standard

NEMA  XR 24-2008 (R2014)
Primary user controls for interventional angiography x-ray equipment

Scope/Abstract

Offers a unified approach to primary user control function as a means of ensuring that the method of control for interventional x-ray equipment is consistent for all manufacturers.

Extent of Recognition

Complete standard

Public Law, CFR Citation(s) and Procode(s)*

Regulation Number	Device Name	Device Class	Product Code
§892.1650	System, X-Ray, Fluoroscopic, Image-Intensified	Class 2	JAA
§892.1680	Solid State X-Ray Imager (Flat Panel/Digital Imager)	Class 2	MQB
§892.1700	Generator, High-Voltage, X-Ray, Diagnostic	Class 1	IZO
§892.1720	System, X-Ray, Mobile	Class 2	IZL

Relevant FDA Guidance and/or Supportive Publications*

Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices - Guidance for Industry and Food and Drug Administration Staff, issued September 2018.

Standards Development Organization

NEMA National Electrical Manufacturers Association https://www.nema.org/

FDA Specialty Task Group (STG)

Radiology

*These are provided as examples and others may be applicable.