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U.S. Department of Health and Human Services

Product Classification
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Device confocal optical imaging
Regulation Description Endoscope and accessories.
Definition Collection of light signals for visualization of cellular microstructures.
Physical State Usually include optical fibers, light collection cameras and computer-based central processing unit
Technical Method Collects reflected and scattered light signals from the areas of interest for image reconstruction
Target Area soft tissue, blood vessel and other vessels in the body
Regulation Medical Specialty Gastroenterology/Urology
Review Panel General & Plastic Surgery
Product CodeOWN
Premarket Review Office of Surgical and Infection Control Devices (OHT4)
General Surgery Devices (DHT4A)
Submission Type 510(k)
Regulation Number 876.1500
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
Third Party Review Not Third Party Eligible
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