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
• Submission Type: 510(k)
• Regulation Number: 892.1560
• 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
• 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

Third Party Review

Not Third Party Eligible