Recognized Consensus Standards

Recognition List Number: 013 Publication Date: 10/31/2005 

Part B: SUPPLEMENTARY INFORMATION

Recognition Number 12-79: NEMA XR7-1995 (R2000), High-Voltage X-Ray Cable Assemblies and Receptacles. (Radiology)

Date of Standard: 1995. 

Address of Standards Organization:

  National Electrical Manufacturers Association (NEMA)

  1300 North 17th Street

  Suite 1847

  Rosslyn, VA 22209

CDRH Office and Division Associated with Recognized Standards:

	OFFICE OF DEVICE EVALUATION (ODE)

Devices Affected:

Diagnostic medical X-ray equipment from 10kV to 200kV

Processes Affected:

510(k)

Type of Standard:

 National, Vertical

Extent of Recognition:

Complete standard and any annexes

Related CFR Citations and Product Codes:

Regulation Number	Device Name	Device Class	Product Code
§892.1630	System, Imaging, X-Ray, Electrostatic	Class 2	IXK
Regulation Number	Device Name	Device Class	Product Code
§892.1650	Solid State X-Ray Imager (Flat Panel/Digital Imager)	Class 2	MQB
§892.1650	System, X-Ray, Fluoroscopic, Image-Intensified	Class 2	JAA
Regulation Number	Device Name	Device Class	Product Code
§892.1660	System, X-Ray, Fluoroscopic, Non-Image-Intensified	Class 2	JAB
Regulation Number	Device Name	Device Class	Product Code
§892.1680	System, X-Ray, Stationary	Class 2	KPR
Regulation Number	Device Name	Device Class	Product Code
§892.1700	Generator, High-Voltage, X-Ray, Diagnostic	Class 1	IZO
Regulation Number	Device Name	Device Class	Product Code
§892.1710	System, X-Ray, Mammographic	Class 2	IZH
Regulation Number	Device Name	Device Class	Product Code
§892.1730	System, X-Ray, Photofluorographic	Class 2	IZG
Regulation Number	Device Name	Device Class	Product Code
§892.1740	System, X-Ray, Tomographic	Class 2	IZF
Regulation Number	Device Name	Device Class	Product Code
§892.1750	System, X-Ray, Tomography, Computed	Class 2	JAK
Regulation Number	Device Name	Device Class	Product Code
§892.1760	Assembly, Tube Housing, X-Ray, Diagnostic	Class 1	ITY

Relevant Guidance:

There is no relevant guidance developed at this time.

FDA Technical Contact:

  Robert A. Phillips

  FDA/CDRH/ODE

  9200 CORPORATE BLVD, HFZ-470

  Rockville MD 20850

  240/276-3658

  Email: robert.phillips@fda.hhs.gov