Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • 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
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search Back To Search Results
Recognition List Number: 028 Publication Date: 03/16/2012 

Part B: SUPPLEMENTARY INFORMATION

Recognition Number 12-235: IEC 60731 Edition 3.0 2011-02, Amendment 1, Medical electrical equipment - Dosimeters with ionization chambers as used in radiotherapy. (Radiology)

Date of Standard: 2011. 
Address of Standards Organization:
  International Electrotechnical Commission (IEC)
  3, Rue de Varembe'
  PO Box 131
  CH-1211 Geneva 20, 0
  SWITZERLAND
CDRH Office and Division Associated with Recognized Standards:
OFFICE OF IN VITRO DIAGNOSTICS AND RADIOLOGICAL HEALTH (OIR)
Devices Affected:
Dosimeters used in Radiation Therapy
Processes Affected:
510(k), PMA, IDE, HDE, PDP
Type of Standard:
 International, Vertical
Extent of Recognition:
Complete standard and any annexes and amendments
Related CFR Citations and Product Codes:
Regulation
Number		 Device Name Device
Class		 Product
Code
§892.5050 Accelerator, Linear, Medical Class 2 IYE
§892.5050 Accessory - Film Dosimetry System Class 2 MWW
§892.5050 Betatron, Medical Class 2 IYG
§892.5050 Cyclotron, Medical Class 2 IWK
§892.5050 Microtron, Medical Class 2 JAE
§892.5050 Synchrotron, Medical Class 2 IWM
§892.5050 System, Radiation Therapy, Charged-Particle, Medical Class 2 LHN
§892.5050 System,Planning,Radiation Therapy Treatment Class 2 MUJ
 
Regulation
Number		 Device Name Device
Class		 Product
Code
§892.5750 Device, Beam Limiting, Teletherapy, Radionuclide Class 2 IWD
§892.5750 System, Radiation Therapy, Radionuclide Class 2 IWB
 
Regulation
Number		 Device Name Device
Class		 Product
Code
§892.5900 Collimator, Dermatological, Therapeutic X-Ray Class 2 IYL
§892.5900 Collimator, High Voltage, Therapeutic X-Ray Class 2 IYK
§892.5900 Collimator, Low Voltage, Therapeutic X-Ray Class 2 IYJ
§892.5900 Collimator, Orthovoltage, Therapeutic X-Ray Class 2 IYI
§892.5900 Device, Beam Limiting, X-Ray, Therapeutic Class 2 KQA
§892.5900 Generator, Dermatological (Grenz Ray), Therapeutic X-Ray Class 2 IYH
§892.5900 Generator, High Voltage, X-Ray, Therapeutic Class 2 KPZ
§892.5900 Generator, Low Voltage, Therapeutic X-Ray Class 2 IYD
§892.5900 Generator, Orthovoltage, Therapeutic X-Ray Class 2 IYC
§892.5900 System, Therapeutic, X-Ray Class 2 JAD
 
Relevant Guidance:
There is no relevant guidance developed at this time.
FDA Technical Contact:
  John Chen
  FDA/CDRH/OIVD
  10903 New Hampshire Avenue Building 66, Room G302
  Silver Spring MD 20993
  301/796-6540
  Email: john.chen@fda.hhs.gov
* In the United States, copies of this standard can be obtained from:
  American National Standards Institute (ANSI)*
  25 West 43rd Street
  4th Floor
  New York, NY 10036
-
-