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U.S. Department of Health and Human Services

Recognized Consensus Standards: Medical Devices
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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
Rationale for Recognition
This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies.
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.
FDA Technical Contact
 Donald Miller
  FDA/OC/CDRH/OPEQ/OIDRH/
  301-796-3299
  Donald.Miller@fda.hhs.gov
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.
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