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
• Premarket Review: Office of Radiological Health (OHT8); Division of Radiological Imaging and Radiation Therapy Devices (DHT8C)
• Submission Type: 510(k)
• Regulation Number: 892.1550
• Device Class: 2
• Total Product Life Cycle (TPLC): TPLC Product Code Report
• GMP Exempt?: No
• Summary Malfunction Reporting: Eligible
• Implanted Device?: No
• Life-Sustain/Support Device?: No

Recognized Consensus Standards

• 12-105 NEMA UD 2-2004 (R2009)
  Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment Revision 3
• 12-228 IEC 61391-2 Edition 1.0 2010-01
  Ultrasonics - Pulse-echo scanners - Part 2: Measurement of maximum depth of penetration and local dynamic range
• 12-279 IEC 62127-03 Edition 1.1 2013-05
  Ultrasonics -- Hydrophones -- Part 3: Properties of hydrophones for ultrasonic fields up to 40 MHz
• 12-291 IEC 62127-2 Edition 1.2 2017-03 CONSOLIDATED VERSION
  Ultrasonics -- Hydrophones -- Part 2: Calibration for ultrasonic fields up to 40 MHz
• 12-292 IEEE Std 3333.2.1-2015
  IEEE Recommended Practice for Three-Dimensional (3D) Medical Modeling
• 12-293 IEC 60601-2-37 Edition 2.1 2015
  Medical electrical equipment - Part 2-37: Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment
• 12-312 IEC 61391-1 Edition 1.1 2017-07 CONSOLIDATED VERSION
  Ultrasonics - Pulse-echo scanners - Part 1: Techniques for calibrating spatial measurement systems and measurement of system point-spread function response
• 12-316 IEC 62359 Edition 2.1 2017-09 CONSOLIDATED VERSION
  Ultrasonics - Field characterization - Test methods for the determination of thermal and mechanical indices related to medical diagnostic ultrasonic fields
• 12-343 IEC 62127-1 Edition 2.0 2022-03
  Ultrasonics - Hydrophones - Part 1: Measurement and characterization of medical ultrasonic fields

Third Party Review

• Eligible for 510(k) Third Party Review Program

Accredited Persons

• center for measurement standards of industrial
• global quality and regulatory services
• regulatory technology services, llc
• third party review group, llc