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U.S. Department of Health and Human Services

Product Classification

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Device gastrointesinal lesion software detection system
Regulation Description Gastrointestinal lesion software detection system.
Definition A gastrointestinal lesion software detection system is a computer-assisted detection device used in conjunction with endoscopy for the detection of abnormal lesions in the gastrointestinal tract. This device with advanced software algorithms brings attention to images to aid in the detection of lesions. The device may contain hardware to support interfacing with an endoscope.
Physical State The device is a software, which may contain hardware components for enabling compatibility with endoscopic devices.
Technical Method The device is a software that uses artificial intelligence/machine learning (AI/ML) advanced algorithms to aid in detection colonic mucosal lesions via endoscopy in real-time.
Target Area Gastrointestinal tract
Regulation Medical Specialty Gastroenterology/Urology
Review Panel Gastroenterology/Urology
Product CodeQNP
Premarket Review Office of Gastrorenal, ObGyn, General Hospital, and Urology Devices (OHT3)
Renal, Gastrointestinal, Obesity and Transplant Devices (DHT3A)
Submission Type 510(k)
Regulation Number 876.1520
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Implanted Device? No
Life-Sustain/Support Device? No
Recognized Consensus Standards
Third Party Review Not Third Party Eligible