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

Part B: Supplementary Information

Recognition Number 12-275: IEC 61161 Edition 3.0 2013-01, ultrasonics -- power measurement -- radiation force balances and performance requirements. (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 SCIENCE AND ENGINEERING LABORATORIES (OSEL)
(2)OFFICE OF COMPLIANCE (OC)
(3)OFFICE OF IN VITRO DIAGNOSTICS AND RADIOLOGICAL HEALTH (OIR)
(4)OFFICE OF SURVEILLANCE AND BIOMETRICS (OSB)
(5)OFFICE OF DEVICE EVALUATION (ODE)
Devices Affected:
Diagnostic Ultrasound Devices, Physiotherapy Ultrasound Devices, Ultrasound Diathermy 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 Applicator, Hyperthermia, Deep Heating, Ultrasound Class 3 LNB
Unclassified Automated Breast Ultrasound Class 3 PAA
Unclassified Ultrasound,Hyperthermia, Cancer Treatment Class 3 LSY
§870.1200 Catheter, Ultrasound, Intravascular Class 2 OBJ
§870.1200 Reprocessed Intravascular Ultrasound Catheter Class 2 OWQ
§870.1200 Ultrasound, Infusion, System Class 2 NUI
§890.5300 Diathermy, Ultrasonic, For Use Other Than Applying Therapeutic Deep Heat Class 3 LXF
§890.5300 Stationary Ultrasonic Diathermy Device For Use In Applying Therapeutic Deep Heat Class 2 PFW
§890.5300 Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat Class 2 IMI
§878.4410 Ultrasound, Skin Permeation Class 2 NRJ
§878.4410 Wound Cleaner, Ultrasound Class 2 NRB
§890.5860 Stimulator, Ultrasound And Muscle, For Use In Applying Therapeutic Deep Heat Class 2 IMG
§892.1570 Diagnostic Ultrasonic Transducer, Robotic Class 2 OQQ
§892.1570 Transducer, Ultrasonic, Diagnostic Class 2 ITX
Relevant Guidance:
FDA Diagnostic Ultrasound Guidance, ¿Information for Manufacturers Seeking Marketing Clearance of
Diagnostic Ultrasound Systems and Transducers¿. Document issued on: September 9, 2008
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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