• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Recognized Consensus Standards

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | Registration & Listing | Adverse Events | Recalls | PMA | Classification | Standards | Inspections
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search Back To Search Results
Recognition List Number: 013 FR 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 Development 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:
 Vertical, National
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
§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
§892.1660 System, X-Ray, Fluoroscopic, Non-Image-Intensified Class 2 JAB
§892.1680 System, X-Ray, Stationary Class 2 KPR
§892.1700 Generator, High-Voltage, X-Ray, Diagnostic Class 1 IZO
§892.1710 System, X-Ray, Mammographic Class 2 IZH
§892.1730 System, X-Ray, Photofluorographic Class 2 IZG
§892.1740 System, X-Ray, Tomographic Class 2 IZF
§892.1750 System, X-Ray, Tomography, Computed Class 2 JAK
§892.1760 Assembly, Tube Housing, X-Ray, Diagnostic Class 1 ITY
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
-
-