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U.S. Department of Health and Human Services

Recognized Consensus Standards

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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
Public Law, CFR Citation(s) and Procode(s)*
Regulation Number Device Name Device Class Product Code
§892.1720 System, X-Ray, Mobile Class 2 IZL
§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
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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