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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 12-286
Standard
NEMA  XR 27 Amendment 1-2013
X-ray equipment for interventional procedures - User Quality Control Mode
Scope/Abstract
Applies to x-ray equipment intended to perform interventional procedures and defines a set of minimum set of requirements designed to more easily facilitate quality control at the facility level.
Extent of Recognition
Complete standard
Public Law, CFR Citation(s) and Procode(s)*
Regulation Number Device Name Device Class Product Code
§892.1600 System, X-Ray, Angiographic Class 2 IZI
§892.1650 System, X-Ray, Fluoroscopic, Image-Intensified Class 2 JAA
§892.1650 Interventional Fluoroscopic X-Ray System Class 2 OWB
§892.1650 Image-Intensified Fluoroscopic X-Ray System, Mobile Class 2 OXO
§892.1680 System, X-Ray, Stationary Class 2 KPR
§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
 Scott Gonzalez
  FDA/OC/OPLIA/OGPS/OGO/
  240-705-2401
  scott.gonzalez@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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