Product Classification

• Device: system, imaging, optical coherence tomography (oct)
• Regulation Description: Ultrasonic pulsed echo imaging system.
• Definition: This device uses back-reflected light to create two-dimensional images versus back-reflected sound waves as are used in ultrasound imaging.
• Regulation Medical Specialty: Radiology
• Review Panel: General & Plastic Surgery
• Product Code: NQQ
• Premarket Review: Office of Surgical and Infection Control Devices (OHT4); General Surgery Devices (DHT4A)
• Submission Type: 510(k)
• Regulation Number: 892.1560
• 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

• 12-293 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
• 12-380 IEC 60601-2-37 Edition 3.0 2024-07
  Medical electrical equipment - Part 2-37: Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment

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