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U.S. Department of Health and Human Services

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Recognition List Number: 036 FR Publication Date: 07/09/2014 

Part B: Supplementary Information

Recognition Number 12-281: IEC 60601-2-62 Edition 1.0 2013-07, medical electrical equipment ¿ part 2-62: particular requirements for the basic safety and essential performance of high intensity therapeutic ultrasound (hitu) equipment. (Radiology)

Date of Standard: 2013. 
Address of Standards Development Organization:
 International Electrotechnical Commission (IEC)
  3, Rue de Varembe'
  PO Box 131
  CH-1211 Geneva 20, 0
  SWITZERLAND
CDRH Offices and Divisions associated with recognized standards:
(1)OFFICE OF DEVICE EVALUATION (ODE)
(2)OFFICE OF SCIENCE AND ENGINEERING LABORATORIES (OSEL)
Devices Affected:
Ablation system, high intensity focused ultrasound (hifu), MR-guided applicator, hyperthermia, deep heating, ultrasound focused ultrasound for tissue heat or mechanical cellular disruption system, ablation, ultrasound and accessories
Processes Affected:
510(k), PMA, PDP, IDE, HDE
Type of Standard:
 Vertical, International
Extent of Recognition:
Complete standard
Related CFR Citations and Product Codes:
Regulation
Number
Device Name Device
Class
Product
Code
Unclassified Ablation System, High Intensity Focused Ultrasound (Hifu), Mr-Guided Class 3 NRZ
Unclassified Applicator, Hyperthermia, Deep Heating, Ultrasound Class 3 LNB
§878.4400 System, Ablation, Ultrasound And Accessories Class 2 NTB
§878.4590 Focused Ultrasound For Tissue Heat Or Mechanical Cellular Disruption Class 2 OHV
FDA Technical Contact:
 Keith Wear
  FDA/CDRH/OSEL
  10903 New Hampshire Avenue Building 62, Room 3108
  Silver Spring MD 20993
  301/796-2538
  email: keith.wear@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
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