Product Classification

• Device: media, coupling, ultrasound
• Regulation Description: Diagnostic ultrasonic transducer.
• Regulation Medical Specialty: Radiology
• Review Panel: Radiology
• Product Code: MUI
• Premarket Review: Office of Radiological Health (OHT8); Radiological Imaging and Radiation Therapy Devices (DHT8C)
• Submission Type: 510(k)
• Regulation Number: 892.1570
• 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
• 12-293 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
• 12-316 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

Third Party Review

• Eligible for 510(k) Third Party Review Program

Accredited Persons

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