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

Part B: Supplementary Information

Recognition Number 12-280: IEC 62555 Edition 1.0 2013-11, ultrasonics -- power measurement -- high intensity therapeutic ultrasound (hitu) transducers and systems. (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 IN VITRO DIAGNOSTICS AND RADIOLOGICAL HEALTH (OIR)
(2)OFFICE OF SURVEILLANCE AND BIOMETRICS (OSB)
(3)OFFICE OF DEVICE EVALUATION (ODE)
(4)OFFICE OF DEVICE EVALUATION (ODE)
(5)OFFICE OF SCIENCE AND ENGINEERING LABORATORIES (OSEL)
(6)OFFICE OF COMPLIANCE (OC)
Devices Affected:
High Intensity Therapeutic Ultrasound Devices, High Intensity Focused Ultrasound Devices
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 Device, Ultrasonic, Thermal Ablation Class 3 MIK
§878.4590 Focused Ultrasound For Tissue Heat Or Mechanical Cellular Disruption Class 2 OHV
FDA Technical Contact:
 Subha Maruvada
  FDA/CDRH/OSEL
  10903 New Hampshire Avenue Building 62, Room 2222
  Silver Spring MD 20993
  301/796-2524
  email: subha.maruvada@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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