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U.S. Department of Health and Human Services

Product Classification
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Device endoscope, accessories, image post-processing for color enhancement
Definition Alternative mode of visualization using image post-processing algorithms of the received white light image for color enhancement.
Physical State The system consists of flexible and/or rigid scope(s), light source(s), video processor and display.
Technical Method Image enhancement using image post-processing algorithms of the received white light image with the goal of enhancing visualization of suspicious images seen on white light.
Target Area Limited to endoscopic systems for observation of the gastro-urological tract.
Regulation Medical Specialty Gastroenterology/Urology
Review Panel Gastroenterology/Urology
Product CodePEA
Premarket Review GastroRenal, ObGyn, General Hospital, and Urology Devices (OHT3)
Renal, Gastrointestinal, Obesity and Transplant Devices (DHT3A)
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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