Product Classification

• Device: diagnostic ultrasonic transducer, robotic
• Regulation Description: Diagnostic ultrasonic transducer.
• Definition: Diagnostic ultrasonic imaging or monitoring.
• Physical State: piezoelectric material
• Technical Method: Robotic component maintains signal and recovers lost signal.
• Target Area: Unspecified
• Regulation Medical Specialty: Radiology
• Review Panel: Radiology
• Product Code: OQQ
• Premarket Review: Office of Radiological Health (OHT8); Division of 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 Standard

• 12-275 IEC 61161 Edition 3.0 2013-01
  Ultrasonics -- Power measurement -- Radiation force balances and performance requirements

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