Product Classification

• Device: system, imaging, pulsed doppler, ultrasonic
• Regulation Description: Ultrasonic pulsed doppler imaging system.
• Regulation Medical Specialty: Radiology
• Review Panel: Radiology
• Product Code: IYN
• Submission Type: 510(k)
• Regulation Number: 892.1550
• Device Class: 2
• Total Product Life Cycle (TPLC): TPLC Product Code Report
• GMP Exempt?: No

Recognized Consensus Standards

• AIUM AOL 2008 Acoustic Output Labeling Standard for Diagnostic Ultrasound Equipment Revision 1 - A Standard for How Manufacturers Should Specify Acoustic Output Data
• AIUM AOMS-2004 Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment
• IEC 60601-2-37 (2004) (2005) Amendment 2 Medical electrical equipment - Part 2-37: Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment
• IEC 61391-2 Edition 1.0 2010-01 Ultrasonics - Pulse-echo scanners - Part 2: Measurement of maximum depth of penetration and local dynamic range
• IEC 61391-1 First edition 2006-07 Ultrasonics - Pulse-echo scanners - Part 1: Techniques for calibrating spatial measurement systems and measurement of system point-spread function response
• NEMA UD 3-2004 (R2009) Standard for Real Time Display of Thermal and Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment
• NEMA UD 2-2004 (R2009) Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment Revision 3
• AIUM RTD2-2004 Standard for Real-Time Display of Thermal and Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment Revision 2
• IEC 62359 Edition 2.0 2010-10-10 Ultrasonics - Field characterization - Test methods for the determination of thermal and mechanical indices related to medical diagnostic ultrasonic fields
• IEC 62359 (Second edition 2010) March 2011 Ultrasonics - Field charactization - Test methods for the determination of thermal and mechanical indices related to medical diagnostic ultrasonic fields Corrigendum 1
• AIUM MUS Medical Ultrasound Safety

Guidance Document

• Guidance for Industry and FDA Staff - Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers

Third Party Review

• Eligible for Accredited Persons Program

Accredited Persons

• bsi healthcare
• center for measurement standards of industrial
• dekra certification b.v.
• intertek testing services
• regulatory technology services, llc
• tuv sud america inc.
• underwriters laboratories, inc.