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U.S. Department of Health and Human Services

Product Classification

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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 CodeNQQ
Premarket Review Office of Device Evaluation (ODE)
Division of Surgical Devices (DSD)
General Surgery Devices Branch One - Light Based/Laser (GSDB1)
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
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible