Recognized Consensus Standards

Recognition List Number: 028 Publication Date: 03/16/2012 

Part B: SUPPLEMENTARY INFORMATION

Recognition Number 12-100: NEMA UD 3-2004 (R2009), Standard for Real Time Display of Thermal and Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment. (Radiology)

Date of Standard: 2004. 

Address of Standards 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 IN VITRO DIAGNOSTICS AND RADIOLOGICAL HEALTH (OIR)

Devices Affected:

Non-Fetal Ultrasonic Monitor, Ultrasonic Pulsed Doppler Imaging System, Ultrasonic Pulsed Echo Imaging System, Diagnostic Ultrasound Transducer

Processes Affected:

510(k)

Type of Standard:

 National, Vertical

Extent of Recognition:

Complete standard and any annexes

Related CFR Citations and Product Codes:

Regulation Number	Device Name	Device Class	Product Code
§892.1540	Monitor, Ultrasonic, Nonfetal	Class 2	JAF
Regulation Number	Device Name	Device Class	Product Code
§892.1550	System, Imaging, Pulsed Doppler, Ultrasonic	Class 2	IYN
Regulation Number	Device Name	Device Class	Product Code
§892.1560	System, Imaging, Pulsed Echo, Ultrasonic	Class 2	IYO
Regulation Number	Device Name	Device Class	Product Code
§892.1570	Media,Coupling,Ultrasound	Class 2	MUI
§892.1570	Transducer, Ultrasonic, Diagnostic	Class 2	ITX

Relevant Guidance:

Guidance for Industry and FDA Staff Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers Document issued on: September 9, 2008

FDA Technical Contacts:

Gerald Harris   FDA/CDRH/OSEL   10903 New Hampshire Avenue Building 62, Room 2104   Silver Spring MD 20993   301/796-2508   Email: gerald.harris@fda.hhs.gov

Lauren N. Hefner   FDA/CDRH/OIVD   10903 New Hampshire Avenue Building 66, Room G312   Silver Spring MD 20993   301/796-6881   Email: lauren.hefner@fda.hhs.gov